Section 25.214. Recordkeeping

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).