A registrant shall, upon the consummation of a sale of a hearing aid, keep and maintain records in the registrant’s office or place of business at all times. These records shall be kept for 7 years and shall include the following:
(1) Results of all testing conducted under § 25.209 (relating to facilities, procedures and instrumentation). The minimum acceptable test records shall be records of:
- (i) Pure tone tests including air and bone conduction with masking where appropriate, and the ambient noise level of the test area.
- (ii) Speech reception threshold expressed in decibels of hearing level.
- (iii) Most comfortable level expressed in decibels.
- (iv) Uncomfortable (tolerance) level expressed in decibels.
- (v) Word discrimination test results expressed in percentage indicating the test words used, presentation level, masking level (if applicable), and signal to noise ratio (if applicable).
- (2) A copy of the written receipt, disclosure agreement and money back guarantee required by § 25.210 (relating to receipt, disclosure agreement and money back guarantee to purchaser—purchaser protection).
- (3) The written physician’s recommendation required by § 25.212 (relating to medical recommendations by examining physicians) or the waiver form required by § 25.211 (relating to medical recommendations; waiver forms).