North Carolina General Statutes Chapter 90. Medicine and Allied Occupations § 90-308. Disclosure of locked hearing aid software by audiologists;  receipt and record requirements

(a) Disclosure of Locked, Nonproprietary or Proprietary Programming Software.--To the extent not inconsistent with federal law, a licensed audiologist who engages in the fitting or selling of locked hearing aids, as defined in G.S. 93D-7.1(a)(1), shall, at the time of purchase of any locked hearing aid, provide the purchasing patient with a written notice in at least 12-point type stating:

“The locked hearing aid being purchased uses locked, nonproprietary or proprietary programming software and can only be serviced or programmed at specific facilities or locations.”

The purchasing patient shall sign the notice at the time of purchase with physical signature or electronic signature.  The audiologist shall retain a copy of the signed notice in the patient's file in addition to the record requirements of subsection (c) of this section.

(b) Written Receipt of Sale.--Upon the consummation of a sale of a locked hearing aid, in addition to complying with G.S. 93D-7, the audiologist shall give the purchasing patient a written receipt signed, with physical or electronic signature, by or on behalf of the audiologist and the patient, containing all of the following information:

If multiple locked hearing aids are sold in a single transaction, a single written notice under subsection (a) of this section and a single written receipt under this subsection may be used to satisfy the requirements of this section, provided that the required information for each locked hearing aid sold is documented.

(c) Record Keeping.--A licensed audiologist shall maintain, for a period of at least three years after the sale of a locked hearing aid, the following records for each locked hearing aid transaction:

These records shall be kept at the audiologist's principal place of practice and shall be made available for inspection by the Board.