DEPARTMENT OF HEALTH
[28 PA. CODE CH. 25]
Hearing Aid Sales and Registration
[32 Pa.B. 3223]
The Department of Health (Department) proposes to amend Chapter 25 (relating to controlled substances, drugs, devices and cosmetics). The proposed amendments are set forth in Annex A.
A. Purpose and Procedure
The proposed amendments are intended to facilitate implementation of amendments made to the Hearing Aid Sales Registration Law (act) (35 P. S. §§ 6700-101--6700-802) by the act of December 21, 1998 (P. L. 1190, No. 153) (Act 153), and to otherwise bring up to date the regulations promulgated under the act. The act governs the sale of hearing aids and regulates the related activities of hearing aid dealers and fitters. It imposes duties upon, and prohibits certain acts by, hearing aid dealers and fitters, and provides for penalties that may include denial, suspension, or revocation of a dealer's or fitter's registration. The changes made by Act 153 included imposing continuing education requirements upon hearing aid fitters and making failure to comply with those requirements a cause for denial, suspension or revocation of a registration certificate. Act 153 also raised the fees for registration certificates, and required disclosure agreements and money-back-guarantees to be provided to purchasers and prospective purchasers of hearing aids.
The proposed amendments are also responsive to Federal preemption of certain portions of the act due to regulations promulgated by the Federal Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. §§ 301--397) specifically section 521 (21 U.S.C.A. § 360k). The Federal regulations regarding hearing aids are published at 21 CFR 801.420 and 801.421 (relating to hearing aid devices; professional and patient labeling; and hearing aid devices; conditions for sale). A few Commonwealth requirements that conflict with the Federal regulations were conditionally exempted from preemption under the final rule issued by the FDA in Docket No. 77N-0333, dated October 10, 1980 (45 FR 67321) (Final Rule). These will be discussed. Other amendments are proposed for the sake of clarity or correctness, to fix typographical errors, or to bring the regulations into compliance with the Pennsylvania Code and Bulletin Style Manual. Proposed grammatical changes will not be discussed. A number of amendments have been proposed to ensure that terms are used consistently, including the use of ''registrant'' to refer to dealers and fitters, and ''prospective hearing aid user'' to refer to one who is being evaluated but who has not purchased a hearing aid. Additionally, the term ''authorized representative'' would be defined and used to clarify that one who fits the definition of ''authorized representative'' may act for a prospective hearing aid user. Also proposed is the addition of a ''Subchapter B'' heading for §§ 25.201--25.221, entitled ''Hearing Aid Sales and Registration,'' to differentiate the hearing aid regulations from regulations in proposed new ''Subchapter A,'' entitled ''Controlled Substances, Drugs, Devices and Cosmetics.''
Following the passage of Act 153, stakeholders began contacting the Department with suggestions and ideas for the revised regulations, and draft proposed regulations were formulated. In drafting the proposed changes to the regulations, the Department has taken into account the recommendations of the Hearing Aid Advisory Council (Council), as well as the written and oral comments that have been made in response to the draft proposed regulations by stakeholders, primarily members of the regulated community. Changes made in response to this input include the proposed updating or removal of archaic technical requirements, and proposed changes to more accurately reflect the procedures followed by the Department in administering examinations to hearing aid fitters and in registering both dealers and fitters.
In addition to enforcement responsibilities this act confers upon the Department, the act also confers enforcement responsibilities upon the Office of Attorney General and district attorneys offices. In developing the proposed amendments, the Department consulted with the Office of Attorney General, in particular, its Bureau of Consumer Protection.
B. Summary of the Proposed Amendments.
It is proposed that the chapter be divided into Subchapters A and B to separate the hearing aid regulations from the other regulations in the chapter. Proposed Subchapter B would include regulations adopted under the act, while proposed Subchapter A would include regulations adopted under The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101--780-144).
Section 25.201. Application.
This section sets out the scope of the regulations that would comprise Subchapter B and the Department's authority to adopt these regulations. The proposed changes are made to enhance clarity and to substitute a reference to Subchapter B for the present reference to the span of regulations that would comprise that subchapter. Removal of the term ''surgeon'' is proposed in this section and throughout the regulations, as that term is encompassed by the term ''physician.'' This change was suggested by a stakeholder during the drafting process.
Section 25.202. Definitions.
This section defines the relevant terms used in the regulations that would comprise Subchapter B. The Department proposes several amendments to this section. The Department seeks to clarify that information or documentation required to be provided to a prospective hearing aid user must also be provided to a person authorized to act on behalf of the prospective user. The Department, therefore, proposes to include the term ''authorized representative,'' and to define that term as being a person who is authorized by law to make a decision for a hearing aid user or prospective user. Defining the term ''physician,'' as proposed, will provide consistency with regulations in other chapters of the Department's regulations, and clarify that the term refers to a medical or osteopathic medical doctor who has a currently registered license to practice in this Commonwealth.
The definition of ''advertise and any of its variants'' would be revised to include the use of the Internet for advertising purposes. This change is certainly a necessary one, given the ubiquity and ease of Internet marketing and advertising.
The proposed addition of the term ''used hearing aid'' is made under an FDA requirement. Federal regulations require that a statement identifying a used or rebuilt hearing aid must appear on the package and on a tag attached to the hearing aid, and may also appear in the ''User Instructional Brochure.'' (See 21 CFR 801.420(c)(5)). The Commonwealth's requirement that the receipts provided to hearing aid purchasers must also identify used or reconditioned hearing aids as such could, therefore, have been preempted. However, the FDA decided to exempt the Commonwealth's requirement from preemption contingent on the Commonwealth applying the Federal definition of ''used hearing aid.'' To comply with this directive, the proposed definition of ''used hearing aid'' is included. It is substantially the same as the Federal definition.
The definition of ''continuing education program'' is included to label a program that the Department will recognize towards satisfaction of the continuing education requirements effected by Act 153. Hearing aid fitters are now required to secure continuing education credits to renew their registrations. Finally, a new definition of the term ''audiologist'' is proposed to more accurately reflect the regulatory scheme governing that profession.
Section 25.203. Advisory Council.
This section sets out the requirements for the Council, established under section 201 of the act (35 P. S. § 6700-201). It is proposed that subsection (c)(2), which pertains to Council meetings, be removed. The requirements of the paragraph are too rigid and relate to internal Department matters that do not need to be addressed by regulation. The Department will, of course, coordinate with Council members to schedule Council meetings and make every effort to give Council members timely notice of meetings far in advance. The few remaining proposed changes are to improve clarity and consistency of language.
Section 25.204. Application for and renewal of registration.
This section sets out the process of applying for or renewing a registration, as required by sections 301 and 312 of the act (35 P. S. §§ 6700-301 and 6700-312). The proposed change in the title of the section simply gives the reader notice that the requirements of the section apply to both registration and renewal of registration.
A proposed change to subsection (b) would clarify that the $50 registration fee for an apprentice hearing aid fitter is separate from the initial $150 fee to take the fitter's examination, and that the amounts may be paid separately. As specified in proposed § 25.207(g) (relating to categories of registrations; fee schedule), an apprentice hearing aid fitter, or the holder of a temporary fitter's registration, who has failed the fitter's examination need only pay an additional examination fee of $50 to take the examination again. The applicant does not have to pay an additional $150 each time the exam is taken. Additional proposed changes to subsections (b) and (c) allow for the Department to approve payment methods other than check or money order to pay registration fees and other amounts that may be due.
The proposed requirement in subsection (b) that a completed application for registration as an apprentice hearing aid fitter shall be filed with the Department at least 30 days prior to the examination applies when an apprentice fitter failed the examination the first time and must reregister as an apprentice. The 30-day requirement does not apply to an apprentice fitter who is applying for a registration certificate for the first time. An apprentice is required to serve in an apprenticeship for at least 4 months prior to taking the exam for the first time. An apprentice cannot even begin the apprenticeship prior to being registered. Therefore, the apprentice fitter who has never been registered previously would already have applied for registration more than 4 months prior to taking the fitter's examination, far in excess of the required 30 days. The 30-day requirement does ensure that an apprentice fitter who is retaking the fitter's examination will reapply for a registration certificate at least 30 days prior to retaking the examination.
Some registrants apply for renewals of registration certificates only a few days before their certificates are due to expire. This creates an unreasonable administrative burden for the Department to process these applications within a few days to prevent the registrations from lapsing. The addition of the proposed requirement in subsection (d) that a renewal must be applied for at least 30 days prior to the expiration of a registration certificate, and the proposed addition of subsection (g), which states that a renewal applied for after that time may not be approved before the certificate expires, are intended to ensure that the Department has a reasonable period of time to process renewal requests. This is especially reasonable in view of the fact that all registration certificates expire on the same date--April 15 of each year. The remaining changes the Department proposes in this section would revise fees to be consistent with changes made by Act 153, and relate that certain registrants must meet continuing education requirements to renew their registrations, which requirements are also imposed by Act 153.
Section 25.205. Additional registration requirements.
This section sets out the requirements for registration as a dealer, fitter or apprentice in addition to those set forth in § 25.204, as well as the requirements for reciprocal or temporary registration. The proposed addition of subsection (c)(3) is intended to address a practical problem. While the regulation allows for registration certificates by endorsement (by the Secretary) to be issued to persons licensed as dealers or fitters by states that maintain reciprocal practice privileges with the Commonwealth, there are no states that actually have those arrangements with the Commonwealth at this time. Therefore, there are no persons currently eligible for registration by endorsement. Proposed subsection (c) informs persons who believe they may be potential registrants by endorsement how they may register, given that registration by endorsement is not an option at this time.
The proposed additions to subsection (d)(2)(ii) are also intended to address a practical problem. The Hearing Aid Program staff receive frequent telephone calls from registrants who are preparing to sponsor an apprentice, asking what should be included in a training program, so that they may prepare the required outline. Section 302 of the act (35 P. S. § 6700-302) states that applicants shall demonstrate thorough knowledge of certain subject areas, which areas will be included on the examination. These subject areas are repeated in the proposed regulatory language. This should provide sufficient guidance for those registrants who are sponsoring apprentices to develop an effective training program.
The remaining changes to this section are proposed by the Department to promote clarity and consistency of language.
Section 25.206. Examinations.
This section deals with the qualifying examination for hearing aid fitters. It addresses matters such as the frequency with which the examination is given, obtaining examination dates, and the determination of passing grades. The changes to this section are proposed by the Department to promote clarity and consistency of language.
Section 25.207. Categories of registrations; fee schedule.
This section sets out application and registration fees for dealers, fitters and apprentices, and other fees provided for by the act. The Department is proposing changes to this section to incorporate the increased registration fees adopted by Act 153. Other changes proposed by the Department include changes to subsections (b) and (c) to clarify that, if an initial registration certificate is issued during the second half of the registered year, only half of the registration fee will be charged. Because all registrations expire on April 15 (under section 311 of the act (35 P. S. § 6700-311)), initial dealer registrations issued between October 15 and April 14 are prorated so that the initial fee is $100, rather than the full $200. However, because initial fitter registrations are always preceded by an exam, and $150 of the initial fee is associated with the exam, initial fees for fitter's registration certificates are not prorated. After an initial registration certificate is issued, all renewals are for a full year. Both dealer and fitter renewals will carry a fee of $100.
Changes to subsection (e) have been proposed to clarify that the part of the registration fee which is charged to the applicant holder of a temporary fitter's registration certificate to take the hearing aid fitter's examination for the first time, which is currently $150, will be refunded if the applicant is ineligible to take the exam. Because a considerable period of time may legitimately elapse between the issuance of a temporary fitter's registration certificate and the registrant taking the fitter's examination, subsection (e) would allow the examination fee to be paid separately from and later than the registration fee for the temporary fitter's certificate (as subsection (f) already explicitly allows apprentice fitters to do).
The proposed changes to subsection (g) serve to illustrate the difference between duplicate certificates, which are issued to replace an original certificate that has been lost or destroyed or so that a registrant has an official copy of the certificate for display in more than one location, and replacement certificates, which are issued upon a name change by the holder of the certificate.
Subsection (i) would state that a $50 delinquency fee applies when an applicant applies for the renewal of a registration certificate more than 30 days after the registration certificate has expired. The act states that such a delinquency fee applies if the registration certificate is renewed more than 30 days after expiration (see section 312 of the act); the proposed language is intended simply to ensure that registrants are aware of that fact. Act 153 increases the delinquency fee from $25 to $50, and increases the fee for renewal of a suspended registration certificate from $50 to $100.
Section 25.208. Display of registration certificates; offices.
This section contains requirements for display and inspection of registration certificates. It also includes various requirements regarding a registrant's place or places of business.
The proposed rewrite of subsection (b) would make explicit the requirement that registrants display a duplicate certificate of registration in each branch office. The registrant would apply for and obtain the duplicate from the Department. In addition to the information contained on the original certificate, the address of the correct branch office would appear on a certificate issued for that office. The change would ensure that the certificate on display shows that the location has been brought to the attention of the Department, as required by the act. An additional proposed change is to address the subject matter currently addressed in subsections (b) and (c), in subsections (c) and (d), respectively, due to the proposed repeal of the current text of subsection (d).
The proposed change to current subsection (b) (proposed subsection (c)) specifies that a registrant shall identify a fixed place of business in an application for registration. This protects the public both by preventing registrants from operating without any fixed place of business, and by ensuring that the Department and hearing aid purchasers can locate and contact registrants. The proposed requirement that a registrant operating out of a residence use a space that is set aside for office purposes protects the public health and safety by ensuring that there is a proper space for testing and for the comfort of the prospective hearing aid user. The deletion of the current text of subsection (d) is proposed because the Department no longer issues the cards bearing the expiration date of registration certificates that are the subject matter of subsection (d). The remaining changes to subsections (c)--(e) are proposed for greater clarity.
Section 25.209. Facilities, procedures and instrumentation.
This section identifies the facilities registrants must provide, the procedures that must be followed in fitting and selling a hearing aid, and the standards with which instruments must be in compliance. The proposed addition of the word ''documented'' in subsection (a)(1) serves to reinforce the requirement, stated in § 25.214(1)(i) (relating to recordkeeping), that records of the ambient noise levels of the test area must be maintained for 7 years as part of the registrant's records.
Several changes are proposed in subsection (b). A number of these are technical changes brought to the attention of the Department by stakeholders, and are intended to more closely reflect current technical standards for testing. They include the addition, in subsection (b)(2)(i), of 8000 Hz to the frequencies at which air conduction tests for hearing level thresholds can be performed, as 8000 Hz is a commonly tested frequency. The frequency of 250 Hz would be removed as an acceptable one for testing hearing level thresholds, as 250 Hz is not really a speech frequency, and is an unreliable test frequency that tends to indicate a greater hearing loss than actually exists. Suggested changes to subsection (b)(2)(iv) and (v) would allow additional methods to be used to determine how well an individual can hear speech. Other proposed changes include references to the use of both head and insert earphones in testing, and the inclusion of speech intelligibility as an area of hearing function that may be improved by the use of hearing aids.
An addition to subsection (b)(1) is proposed to supplement the present prohibition against registrants selling a hearing aid unless the prospective user has had specified hearing tests within the previous 6 months. The section currently exempts sales of identical replacement hearing aids from this requirement, thus enabling identical hearing aids to be sold indefinitely without the hearing aid user being retested. Because the needs of hearing aid users change periodically, it is reasonable to ensure that hearing aid users who wish to purchase an identical hearing aid are retested at least every 12 months.
Section 25.210. Receipt, disclosure agreement and money back guarantee to purchaser--purchaser protection.
This section sets out requirements for written receipts, disclosure agreements and money back guarantees. The Department proposes to divide this section into subsections to deal with additional subject matter. The existing regulation would be incorporated in subsection (a). A minor change to subsection (a) would address stakeholder queries as to whether the act requires receipts to be on a single sheet of paper. The proposed change clarifies that they are not required to be on a single sheet of paper.
The Department further proposes an addition to subsection (a)(2), which currently requires the serial number of the hearing aid to be on the receipt. The change, which allows another identification number to be used if a serial number is not available, addresses the sale of new disposable hearing aids, which do not have serial numbers.
Proposed subsections (b) and (c) are new. They are proposed in response to Act 153 requirements that fitters provide a written disclosure agreement and a written 30-day money back guarantee to hearing aid purchasers to allow them to return the hearing aids for a refund. In keeping with Act 153, the Department's proposed form is written in conformance with the Plain Language Consumer Contract Act (73 P. S. §§ 2201--2212). Proposed subsection (b) would require the disclosure agreement/money back guarantee to be printed in ten-point or larger type. It would further require the registrant to provide the disclosure agreement/money back guarantee prior to the provision of any service relating to the possible sale of a hearing aid and to explain it in detail, as required by the statute.
The Department proposes to require registrants to use a form disclosure agreement that includes the money back guarantee as part of the same document. The use of a single document is proposed because the money back guarantee is closely related to the fees that are a main part of the subject matter of the disclosure agreement. The Department is aware that there has been some confusion on the part of both registrants and hearing aid purchasers as to what fees may be retained by registrants when a hearing aid is returned, and how the cancellation fee is to be calculated. In fact, improper cancellation fees or disclosure agreements are among the leading causes of consumer complaints received by the Department in the last few years.
The Department believes that a very small number of registrants deliberately take advantage of a customer population that, due to the nature of the services offered, includes a large percentage of elderly persons, who are particularly vulnerable to bad practices. However, while some improper disclosure and cancellation practices may be deliberately utilized, there also seems to be genuine misunderstanding by some hearing aid dealers and fitters as to how the law in these areas is to be applied. The Department is therefore proposing that registrants be required to use the form disclosure agreement/money back guarantee the Department is proposing as part of the regulation. This would reduce confusion and protect vulnerable consumers by ensuring insofar as is possible that they receive a full explanation of what they must pay for services and goods and what part of that money may be refunded. This also would clarify the Department's interpretation of the act for the regulated parties and the public at large.
The primary problem that has arisen with regard to the money back guarantee is that, in practice, registrants often charge, in addition to the charge for a hearing aid, fees for services associated with the fitting procedure, such as hearing testing, hearing evaluation, and fitting a hearing aid, and retain those fees in addition to the statutorily permitted cancellation fee when a hearing aid is returned. As a result, registrants sometimes retain several hundred dollars in addition to the statutorily permitted cancellation fee, whereas the purchasers returning the hearing aid believe that they would receive a refund of all money paid except for a maximum cancellation fee of $150 per hearing aid. The Department interprets Act 153 to permit registrants to charge fees for services separately from the price of a hearing aid. The cancellation fee permitted by statute deals solely with, and is calculated based solely upon, the price of the hearing aid and accessories. In other words, the cancellation fee pertains solely to the goods sold, and registrants may properly charge additional fees for services. Those fees are separate from the price of the hearing aid. Because they are attributable to services that have already been rendered, they are not required to be refunded upon the return of a hearing aid.
Although the practice of charging separate fees for services is not necessarily illegal or improper, it has become evident that in many cases registrants have not been making clear to customers that charges for services may be retained or collected by them when a hearing aid is returned, in addition to the cancellation fee, which is calculated based upon the price of a hearing aid and accessories. Indeed, some registrants do not appear to grasp this distinction themselves, and incorrectly represent charges for services as being part of the price of the hearing aid. This misunderstanding on the part of registrants is evident in confusing practices such as stating a single price for a hearing aid on the receipt, which price in fact includes service fees that the registrant intends to retain if the hearing aid is returned. In these cases, even if the service fees are properly itemized on the disclosure agreement, consumers get mixed messages. This problem is compounded when registrants fail to fully explain the disclosure agreement, which no doubt occurs at times. In some cases, registrants add the amounts attributable to fees for services to the price of the hearing aid, and then calculate the cancellation fee based on that amount. The registrants then retain both that cancellation fee and the fees for the services. This is not in keeping with the statute in several respects. First, the cancellation fee is inflated by including amounts not attributable to the actual price of the hearing aid when calculating it. Second, although the statute requires registrants to explain disclosure agreements in detail, in some instances registrants are not giving consumers clear explanations of what amounts paid are attributable to fees for services and what the actual price is for the hearing aid.
Because the statute requires fees, including the cancellation fee, to be itemized and disclosed on the disclosure agreement, and because the frequent confusion as discussed previously implicates both the disclosure agreement and the money back guarantee provisions of the statute, the Department's proposed form addresses both matters. To address the lack of clarity which has been noted in the failure on the part of some registrants to distinguish the difference between fees for services and the price of hearing aids, the proposed form disclosure agreement/money back guarantee is divided into Parts A and B. Part A requires the registrant to list and describe the services offered in the first column, as the statute requires. Part A provides space for the registrant to state the fee for each service, and to clearly identify which amounts are refundable if a hearing aid is returned, and which are not. Further, Part A requires registrants to state, along with the fee, whether the fee will be waived if a hearing aid is purchased. This is included because some registrants follow this practice, and stating it as such serves to clarify that the fees for services are not part of the price of the hearing aid.
Part B of the proposed disclosure agreement/money back guarantee form is devoted to stating the price of each hearing aid and the associated accessories. The only amounts that should be identified as being ''not refundable'' are the cancellation fees for the hearing aids and associated accessories, the combined amount of which is restricted by statute.
The proposed form has three separate places for the potential hearing aid purchaser to sign. Two of these must include the date and time of the signature. The signature required directly under Part B is intended to ensure that the registrant explained the disclosure agreement/money back guarantee, particularly the service fees that will be incurred and the cancellation fees that might be incurred, to the potential purchaser prior to the provision of any service, as required by the statute. Of course, Part B cannot be fully completed prior to providing some service, since the registrant cannot know what hearing aid may be necessary, let alone its price. However, it can and must be preliminarily explained. In any case, the customer's signature on the second signature line, indicating that a sale has been made, must be obtained following the sale. The registrant should be sure that the cancellation fees and money back guarantee are fully understood by the purchaser prior to the second signature being obtained. The customer should be provided with a completed copy of the disclosure agreement before leaving.
The customer should not be asked to sign or initial the box identifying the date of delivery until the customer picks up the hearing aid. At that time, as proposed, the date of delivery must be noted, the customer's initials or signature must be obtained in the block, and the registrant must provide another copy of the form to the purchaser with all purchaser signatures and initials. The Department is proposing to require this additional protection because consumers are often unsure as to when the 30-day return period will end, resulting in disputes between consumers and registrants as to whether a hearing aid was returned within the period allowed. The statute provides that the 30-day return period runs from the date of delivery of the hearing aid, not the date the sale was made. It is hoped that by bringing the date of delivery to the attention of both the registrant and consumer, these disputes will occur less often, as both parties should be clear as to the date by which the hearing aid must be returned to trigger a refund. Again, the registrant is expected to explain these matters clearly to the consumer.
Registrants should expand the form if necessary to fill in the proper information in the blanks provided. The form may also comprise more than one page if necessary; however, it should be clearly identified as being a single document.
The form should not be interpreted to require a charge for services. There are many registrants who charge no fee for fitting services. These registrants need only indicate that the price is zero. If registrants choose to give full refunds if a hearing aid is returned rather than retaining a cancellation fee, they may simply state the entire price of the hearing aids in the ''refundable'' column of Part B. As stated in subsection (c)(3), registrants are certainly permitted to extend the money back guarantee period beyond the statutorily required minimum 30 days. The return period may not, of course, be made shorter than 30 days in contravention of Act 153.
The form disclosure agreement/money back guarantee provides that, if a purchaser cancels an order prior to taking delivery of the hearing aid, the purchaser is entitled to a full refund of the purchase price of hearing aids, and a refund of money paid for services not yet rendered. This rule is dictated by the act, which permits a registrant to charge a cancellation fee for the return of a hearing aid and accessories. If delivery never takes place, the hearing aid and accessories are not returned, so a cancellation fee is not applicable and may not be charged. Registrants do not suffer much, if any, financial impact due to giving full refunds in these circumstances, as hearing aid manufacturers generally give full credit to registrants when hearing aids are returned to the manufacturer prior to a customer having taken delivery. Inclusion of the statement on the disclosure agreement/money back guarantee telling the purchaser that orders cancelled prior to delivery are entitled to full refunds is intended to prevent registrants from representing to purchasers who attempt to cancel orders prior to taking delivery that the purchasers are not allowed to do so. The Department does not believe that this is a widespread practice, but it has occurred, most egregiously in cases when the intended user died shortly after purchase and prior to delivery.
Section 25.211. Medical recommendations; waiver forms.
This section addresses when a medical recommendation made by a physician is required prior to the sale of a hearing aid and sets out a waiver form for use when a written waiver of an exam is permitted. The heading of the section was changed to clarify that the section discusses both medical recommendations, and the right of a prospective hearing aid user to waive a medical exam. The proposed change to subsection (a), specifying that only prospective hearing aid users 18 years of age or older may waive a medical examination, is not a substantive change; that requirement would be moved from the current subsection (b). Proposed subsection (a) also clarifies that the medical waiver shall be signed before the sale of a hearing aid occurs. Note that proposed subsection (a) contains the waiver language mandated by the act as opposed to the Federal waiver language. Because the Commonwealth's waiver language was found by the FDA to be ''substantially similar'' to the Federal one, it was specifically exempted from preemption by the FDA.
The text of subsections (b) and (c) would be deleted; replacement language for both has been proposed. These proposed changes are made largely in response to the Federal preemption of certain portions of the act. Specifically, section 402 of the act (35 P. S. § 6700-402) was preempted to the extent it purports to prohibit registrants from fitting or selling a hearing aid to any person who exhibits certain enumerated physical symptoms without first having a written recommendation from a licensed physician stating that a hearing aid may be beneficial to the person. The FDA declared that contrary to the language of the act, the Commonwealth cannot restrict the right of persons 18 years of age or older to waive an exam based on whether they have certain physical symptoms. The current subsection (b) is invalid because it states that a waiver may not be used for persons having the conditions enumerated in section 402 of the act. The current subsection (c) states that subsection (b) cannot be enforced unless the FDA exempted it from preemption. As stated previously, the FDA did not grant that exemption.
Proposed subsections (a) and (b) require a registrant either to obtain a medical recommendation prior to selling a hearing aid, or to ensure that a prospective user or authorized representative signs a waiver form indicating that the individual wishes to waive the medical examination. Proposed subsection (a) goes on to state when and in what form a waiver of a medical exam is required when dealing with prospective users over 18 years of age. A written waiver form which appears exactly as set out in subsection (a) is required if the prospective hearing aid user elects to waive a medical examination, unless the registrant is selling an identical replacement for a worn out or damaged hearing aid. In the latter event, the Federal waiver form is prescribed by Federal regulation, but use of the Commonwealth form is permitted.
Technically, the Federal waiver form (the language of which is somewhat different than the Commonwealth's, although substantially the same) applies when a registrant is selling a replacement hearing aid. Although the Commonwealth's waiver form was deemed by the FDA to be acceptable for the purposes for which its use is prescribed by the act, the Commonwealth's act provides that neither an examination by a physician nor a waiver are necessary if a registrant is selling replacement parts or accessories, or replacing a worn out or damaged hearing aid. This exception in the act is not mirrored in the Federal regulations. Therefore, although the Commonwealth does not require either a medical exam or waiver when selling replacements, the Federal requirement for a medical evaluation or waiver does apply when the registrant is replacing a worn out or damaged hearing aid. Since the requirement of a medical exam or waiver in those cases is Federal, the Federal waiver form technically would apply. However, because the FDA has stated that the Commonwealth's waiver form is acceptable, the Department encourages its use. It will generate less confusion to substitute the Commonwealth's waiver form for the Federal one when dealing with replacements, than to use the Commonwealth form in some cases and the Federal form in other cases.
Stakeholder input regarding the use of the Federal form indicated that there was some belief that including the full text of the Federal form in the regulations and stating that it could be used when selling a replacement for a worn-out or damaged hearing aid, would be very confusing for registrants. The Department agrees and has not reproduced it. However, the Department has no statutory authority to require registrants to use the Commonwealth form in all circumstances, even though it is acceptable in all circumstances. Therefore, subsection (b), rather than stating that either the Federal or State waiver form may be used, would state that a ''legally proper'' waiver form should be used. Again, it is hoped that registrants will use the Commonwealth waiver form in all circumstances; this is certainly easier for them than trying to remember when the Federal waiver is appropriate and when it is not.
Like proposed subsection (b), proposed subsection (c) clarifies current requirements given the interaction of Federal requirements with the Commonwealth law--in this case, when dealing with prospective hearing aid users that are 18 years of age or younger. The FDA exempted from preemption the Commonwealth's requirement that, for a registrant to sell a hearing aid to an individual 18 years of age or younger, a recommendation for a hearing aid must have been made within the previous 6 months by a physician specializing in otology or otolaryngology. This requirement was not preempted even though it is more stringent than the Federal requirement, which permits the recommendation to be made by any physician. However, the Commonwealth's law does not require any medical examination and recommendation for a person 18 or younger (or any other person) when a hearing aid is being sold to replace an identical hearing aid within 6 months of the purchase of the original one. Conversely, the Federal regulations require a person under the age of 18 to be examined by a licensed physician within 6 months prior to the sale, regardless of whether the hearing aid is an identical replacement aid or not. Because the Commonwealth law is, therefore, less stringent where identical replacement hearing aids are concerned, the Federal requirement that a person under 18 years of age shall have a medical recommendation for a hearing aid from a licensed physician (as opposed to a specialist) applies when the hearing aid in question is an identical replacement being sold within 6 months.
Note that a medical examination be waived for a person under 18 years of age--a physician's (usually a specialist's) recommendation is always required in advance of a sale of a hearing aid for this person. Note also that the requirement for examination by a specialist found in the Commonwealth's law applies to children up to and including 18-year-olds, while the Federal regulations permit prospective hearing aid users who are 18 years of age or older to waive a medical examination. Eighteen-year-olds who are buying new hearing aids are therefore subject to the Commonwealth's requirement for examination by a specialist, but an 18-year-old buying an identical replacement hearing aid may waive a medical examination entirely. This explains the necessity for the potentially confusing (but accurate) use in subsection (a) of the phrase, ''older than 18 years of age,'' while subsection (c) uses both ''18 years of age or younger,'' and ''younger than 18 years of age.''
The requirement of section 402 of the act that registrants shall inform prospective users in writing that it would be in their best interest to consult a physician specializing in diseases of the ear if any of the enumerated conditions are present, survives, as the FDA granted a waiver of that requirement. Proposed subsection (d), therefore, requires registrants to advise prospective purchasers in writing that it would be in their best interest to consult a physician if they exhibit the enumerated conditions. Note that proposed subsection (d)(7) does not repeat the statutory language, which is ''Significant air-bone gap, when generally accepted standards have been applied,'' but instead specifically identifies the current ''generally accepted standards'' in Hz.
Section 25.212. Medical recommendations by examining physicians.
This section provides a statement that is to appear in an equivalent or more detailed form in any medical recommendation for a hearing aid, and requires a birthdate to appear in any recommendation made for an individual 18 years of age or younger. It is proposed that subsection (a) be changed to clarify that a medical recommendation must be signed by an examining physician within 180 days prior to the sale of a hearing aid. Subsection (c) would be deleted as being redundant due to this clarification of subsection (a). The proposed changes to subsection (b) are also made for the purpose of clarity, and do not affect the substantive requirements of the section.
Section 25.213. Consumer review.
This section sets out those documents that a registrant must provide and explain to a prospective hearing aid user or to that individual's authorized representative, and covers additional rules that apply to sales made in a purchaser's residence. The proposed changes to this section promote clarity and consistency of language.
Section 25.214. Recordkeeping.
This section describes the records and information that must be kept and maintained by registrants for 7 years following the sale of a hearing aid. These requirements were not preempted. They were specifically given a waiver by the FDA even though they are more stringent than Federal requirements. The proposed change to paragraph (1)(i) ensures that records will be kept of the ambient noise level of the test area. This will enable the Department to better enforce the related regulatory requirement that registrants provide an appropriate test area, the ambient noise level of which may not exceed 55dB on the A scale of a sound level meter. The changes to paragraph (1)(v) are proposed to incorporate up-to-date technical testing requirements. The proposed changes to paragraph (2) are made in response to the statutory requirements of Act 153, that registrants are to provide purchasers with a disclosure agreement and a written money-back guarantee. These documents must also be retained as part of a registrant's records.
Section 25.215. Denial, revocation or suspension of a registrant's certificate.
This section specifies a number of causes for which the Secretary may deny, suspend, revoke or impose conditions upon registration certificates. The proposed change to paragraph (6) is made to clarify that a registrant's certificate is jeopardized if the registrant employs to perform fitter functions any person unauthorized by law to perform within a fitter's scope of practice. Paragraph (9) includes a proposed change clarifying that an audiologist or physician may legitimately function under a registrant's registration number. The Department proposes to add the phrase ''and fees associated with those services or adjustments'' to paragraph (13)(ii), to explicitly include misrepresentations having to do with fees for services among those offenses that may result in action being taken against a registrant's certificate.
Paragraph (23)(i) would prohibit registrants from making representations that a hearing aid is ''new'' when that is not the case, as when a hearing aid has been rebuilt, and would require registrants to identify used hearing aids as such. As stated previously in discussing the definition of ''used hearing aid,'' the FDA required the Commonwealth to utilize the Federal definition of ''used hearing aid'' to avoid preemption of the act's requirement that used hearing aids be identified as such on sales receipts. Subsequently, Act 153 was adopted. Section 504.1 of the act (35 P. S. § 6700-504.1) appears to permit hearing aids that have been refinished or reconditioned by the hearing aid manufacturer or its agent to be identified as new rather than used, if the hearing aids are subject to all of the warranties and guarantees that would normally accompany a new hearing aid. This interpretation, however, does not comport with the requirement that the Commonwealth abide by the Federal definition of ''used hearing aid,'' and must therefore be understood to be limited to making those hearing aids subject to the money back guarantee that is the subject matter of section 504.1 of the act. Those hearing aids must still be identified as required in paragraph (23)(i).
Proposed paragraph (24)(iv) would prohibit a registrant from making a false, misleading or deceptive representation about another registrant or manufacturer, which representation enhances or is likely to enhance the registrant's own hearing aid related business. Paragraph (27) is proposed in response to the addition of continuing education requirements by Act 153, and clarifies that failing to furnish evidence of having fulfilled those requirements or providing false information regarding continuing education obtained may result in denial, revocation, or suspension of a registrant's certificate.
Section 25.216. Continuing education requirements.
This section, as well as §§ 25.217--25.220, is proposed to facilitate implementation of the continuing education requirements imposed by Act 153.
This proposed section implements the continuing education requirements of Act 153, which provides that the continuing education requirement for renewal of a fitter's registration certificate is 20 hours of credit over the preceding 2 years. Proposed subsection (a) explains that requirements for applicants who have had a certificate for less than 2 years will be calculated by prorating the required credits over the number of months during which the applicant has held a certificate, counting only those months during which the applicant held the certificate for at least 15 days. Proposed subsection (b) states that an expired certificate can be renewed within 5 years of the expiration if 20 hours of continuing education credits have been obtained within the 2 years preceding the request for renewal. Proposed subsection (c) would require a fitter who has a suspended certificate to satisfy the continuing education requirement during the period of suspension so that the general requirements for number of credits are met.
Proposed subsection (d) clarifies that the 2-year period for which credits are required begins running as of April 15, 2002. Demonstrating the high standards to which they hold their profession, hearing aid fitters have already been voluntarily complying with the continuing education requirements of the statute. The program gratefully acknowledges their response, and anticipates that voluntary compliance will continue through the implementation period of the regulations.
Proposed subsection (e) states that acceptable subject matter for a continuing education program includes any subject that contributes directly to the competence, skills and education of a fitter. It further provides that at least one-half of all credits must be obtained in the listed ''core subject'' areas.
Section 25.217. Approval of continuing education programs.
This proposed section states how Department approval of continuing education programs may be obtained, the length of time for which that approval is valid, and how to renew it.
Section 25.218. Credit for continuing education.
This proposed section states how continuing education credits will be obtained and reported, and what credits will be accepted by the Department, including continuing education credits through endorsement, and for self-study, practical courses, and instruction.
Section 25.219. Responsibilities of persons offering continuing education programs.
This proposed section would impose requirements for persons offering continuing education programs, including reporting, course evaluation, record retention and monitoring requirements.
Section 25.220. Right to enter, inspect and obtain records.
This proposed section would require persons who offer continuing education programs to produce documents and other items for copying and inspection upon the request of the Department.
Section 25.221. Exceptions.
This proposed section would allow the Department to grant exceptions to any of the requirements in Subchapter B for good cause shown, except for statutory requirements repeated in the subchapter. This is intended to allow the Department and the regulated public some flexibility in dealing with each other and the requirements of Subchapter B.
C. Statutory Authority
The Department's general authority to promulgate regulations is established by section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)). The Department is given specific authority to promulgate rules and regulations to enforce the act in section 205 of the act (35 P. S. § 6700-205), which section was amended by Act 153 to include the authority to promulgate regulations to effect the new requirements of Act 153.
D. Who is Affected by the Proposed Amendments
The proposed changes would affect hearing aid users and prospective users. Hearing aid dealers and fitters are already required by Act 153 to comply with that statute's new requirements, including requirements that they provide disclosure agreements and money-back guarantees to hearing aid purchasers, and pay increased fees for registration certificates. Hearing aid fitters shall also comply with the act's continuing education requirements. Amending the regulations ensures that all requirements affecting the regulated parties will be in one place and also provides some clarification and updates to requirements that preexisted Act 153.
E. Cost and Paperwork Estimates
The proposed amendments repeat the increased registration fees for hearing aid dealers and fitters imposed by Act 153. Additionally, hearing aid fitters will incur costs to obtain the continuing education credits required by Act 153. Because the fees set forth in the regulations merely repeat the fees imposed by statute, and because the amount of continuing education required is also imposed by statute, virtually all costs directly attributable to the proposed amendments are costs that will be incurred by persons who need to meet regulatory requirements to offer continuing education courses. However, persons offering continuing education credits are permitted to charge persons who attend those courses and may recoup their costs through enrollment fees. One cost that is directly attributable to the regulations will be the cost incurred due to having to make a change to using the Department's proposed disclosure agreement/money back guarantee form. Registrants may also incur some costs due to the establishment, in Act 153, of a 30-day money-back guarantee to purchasers, which may enable purchasers to return hearing aids when registrants otherwise might not have permitted them to do so. However, Act 153 does allow registrants to retain the lesser of $150 or 10% of the purchase price of the items, so it is unlikely that registrants will suffer actual financial loss due to the new requirement.
The proposed amendments will result in some additional paperwork for the Commonwealth in that the Department will be responsible for ensuring that hearing aid fitters have met their continuing education requirements. Hearing aid fitters will also need to retain records enabling them to establish that these requirements are met. Registrants will need to provide to each customer the disclosure agreement and money-back guarantee required by Act 153, and will also be required to retain copies of those documents in their records. Persons who offer continuing education courses will need to satisfy paperwork requirements.
F. Effective/Sunset Dates
The proposed amendments will become effective upon final publication in the Pennsylvania Bulletin. No sunset date is established. The Department will monitor the effectiveness of the regulations on a continuing basis and make changes as needed.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on June 24, 2002, the Department submitted a copy of these proposed amendments to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committee. In addition to submitting the proposed amendments, the Department has provided IRRC and the Committees with a copy of a Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
Under 5(g) of the Regulatory Review Act, if IRRC has any objections to any portion of the proposed amendments, it will notify the Department within 10 days of the close of the Committees' review period. The notification shall specify the regulatory review criteria that have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review of objections raised prior to final publication of the regulations by the Department, the General Assembly and the Governor.
H. Contact Person
Interested persons are invited to submit written comments, suggestions or objections regarding the proposed regulations to Theresa A. Ritchie, R. Ph., Director, Hearing Aid Program, Department of Health, P. O. Box 90, Harrisburg, PA 17108, (717) 783-1379, within 30 days of publication of this notice in the Pennsylvania Bulletin. Persons with a disability who wish to submit comments, suggestions or objections regarding the proposed amendments may do so by using V/TT (717) 783-6514 for speech and/or hearing impaired persons or the Pennsylvania AT&T Relay Service at (800) 654-5984[TT]. Persons who require an alternative format of this document may contact Theresa Ritchie so that necessary arrangements may be made.
ROBERT S. ZIMMERMAN, Jr.,
Fiscal Note: 10-165. (1) General Fund; (2) Implementing Year 2001-02 is $Minimal; (3) 1st Succeeding Year 2002-03 is $Minimal; 2nd Succeeding Year 2003-04 is $Minimal; 3rd Succeeding Year 2004-05 is $Minimal; 4th Succeeding Year 2005-06 is $Minimal; 5th Succeeding Year 2006-07 is $Minimal; (4) 2000-01 Program--$11,958,000; 1999-00 Program--$9,098,000; 1998-99 Program--$8,832,000; (7) Quality Assurance; (8) recommends adoption. These proposed amendments govern the sale of hearing aids and the activities of hearing fitters and dealers and incorporates increased registration fees, continuing education and disclosure agreement requirementsmade by Act 153. The additional costs, not expected to be significant, provide for verification and related activities of the Department and are offset by the registration fees.
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