(1)A licensed hearing instrument specialist shall enter into a written contract for each sale of a hearing instrument which states the terms of the sale.
(2)(a) A licensed hearing instrument specialist shall, at the time of delivery of the hearing instrument, provide the patient with a receipt containing (i) the signature, regular business address, and license number of the licensee, (ii) the brand, model, manufacturer or manufacturer identification code, and serial number of the hearing instrument, and (iii) the amount charged for the hearing instrument.
(b)The receipt shall indicate that the hearing device is classified as programmed with one of the following:
(i)Locked software - this device utilizes locked software that is available to limited providers. The purchase of this device
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(1) A licensed hearing instrument specialist shall enter into a written contract for each sale of a hearing instrument which states the terms of the sale.
(2)(a) A licensed hearing instrument specialist shall, at the time of delivery of the hearing instrument, provide the patient with a receipt containing (i) the signature, regular business address, and license number of the licensee, (ii) the brand, model, manufacturer or manufacturer identification code, and serial number of the hearing instrument, and (iii) the amount charged for the hearing instrument.
(b) The receipt shall indicate that the hearing device is classified as programmed with one of the following:
(i) Locked software - this device utilizes locked software that is available to limited providers. The purchase of this device will require the user to have the device programmed by a provider or chain store that has been granted proprietary access to the software. In addition, the availability of any part or service for this device is limited to the provider or chain store that has such proprietary access; or
(ii) Unlocked software - this device utilizes unlocked software that is readily available to any provider or location licensed to provide hearing health care.
(c) The receipt shall also specify (i) whether the hearing instrument is new, used, or rebuilt, as provided in 21 C.F.R. 801.422, as such regulation existed on January 1, 2025, (ii) the length of time and other terms of the guarantee, and (iii) by whom the hearing instrument is guaranteed.
(3) No hearing instrument may be sold to any person unless both the packaging containing the hearing instrument and the itemized receipt are in compliance with all applicable state and federal laws and regulations.
(4) Upon delivery of the hearing instrument to any person, the licensed hearing instrument specialist shall confirm the physical and operational performance of the hearing instrument. If a patient purchases a hearing instrument from a licensed hearing instrument specialist outside of the licensee's regular place of business and the regular place of business is not within a reasonable distance, as determined by the board, the licensed hearing instrument specialist shall provide the patient with the address of an affiliate location with which the licensee is associated that is within a reasonable distance, at which a licensed hearing instrument specialist or audiologist is available for fitting services.
(5) Any seller offering for sale or selling a hearing instrument in this state or to a resident of this state shall make available in this state an in-person fitting of the hearing instrument by a licensed hearing instrument specialist in this state prior to the sale.
(6) A receipt provided pursuant to this section shall bear in no smaller type than the largest used in the body copy portion the following: The purchaser has been advised at the outset of the relationship with the hearing instrument specialist that any examination or representation made by a licensed hearing instrument specialist in connection with the fitting and selling of this hearing instrument is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state and therefor must not be regarded as medical opinion or advice.