§ 25.209. Facilities, procedures and instrumentation.
(a) Facilities. A registrant shall engage in the practice of fitting or selling a hearing aid only if the registrant provides:
(1) An appropriate test area, the ambient noise level of which shall have a documented readout of 55 dB or lower on the A scale of a sound level meter.
(2) A selection of hearing aid models, supplies and accessories to provide for the immediate needs of hearing aid users or prospective hearing aid users.
(b) Procedures. A registrant shall satisfy the following:
(1) The registrant shall sell a hearing aid only if within 6 months before the sale an examination of the prospective hearing aid user was conducted using pure tone air conduction, bone conduction and speech audiometry tests. This requirement does not apply when the registrant is replacing a hearing aid with another of the same make, model and response. The registrant shall sell a hearing aid replacing another of the same make, model and response only if within 12 months before the sale an examination of the prospective hearing aid user was conducted using pure tone air conduction, bone conduction and speech audiometry tests. The registrant shall verify that the tests were performed by an individual authorized by law to do so. The registrant may rely on a representation by the physician, audiologist or fitter who performed or supervised the tests that the individual who performed the tests was authorized to do so.
(2) The registrant shall:
(i) Perform air conduction tests for hearing level thresholds at frequencies of 250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz and 6,000 Hz or 8,000 Hz, with masking if necessary.
(ii) Perform bone conduction tests for hearing level thresholds at frequencies of 500 Hz, 1,000 Hz, 2,000 Hz and 4,000 Hz, with masking if necessary.
(iii) Maintain records of the test results for each ear for 7 years.
(iv) Perform a speech reception or speech awareness threshold test using an electronic speech audiometer with head or insert ear phones.
(v) Perform a word discrimination or other speech intelligibility test for conversational level speech using an electronic speech audiometer with head or insert ear phones.
(3) The registrant shall sell a hearing aid only if the hearing aid is fitted to the wearer to ensure physical and operational comfort and improvement in hearing function is demonstrated and documented in at least one of the following areas: speech detection, speech awareness levels, speech intelligibility, orientation or speech reception threshhold.
(c) Instrumentation. A registrant shall satisfy the following:
(1) All test instruments shall be calibrated once each year or more often if necessary to meet current American National Standards Institute standards for pure tone and speech audiometry as identified by 1996 A.N.S.I. standards or applicable succeeding A.N.S.I. standards.
(2) Instruments transported to test sites shall be calibrated to the standard set forth in paragraph (1) every 6 months, or more frequently as needed.
(3) Calibration shall be performed by a qualified individual other than the owner.
(4) A signed certificate identifying the most recent date of calibration shall be maintained for inspection by the Department.
Cross References This section cited in 28 Pa. Code § 25.214 (relating to recordkeeping).
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