22/10/2022
Good afternoon,
I am writing on behalf of the Board to provide guidance to licensees on the FDA’s Final Rule on Over the Counter (OTC) Hearing Aids that took effect this past Monday, October 17, 2022. This guidance is intended to assist licensees in understanding the impact of the Final Rule on Nevada laws and regulations in order to ensure the safety and welfare of the public and align practice with regulatory requirements.
RELEVANT FINAL RULE HIGHLIGHTS
OTC hearing aids do not require the involvement of a licensed person. As such, this Board’s laws and regulations do not apply to them.
Non-OTC hearing aids are now defined as prescription devices, but there is no change to the qualifications of who may provide these. Prescription sales are still subject to 21 CFR 801.109.
A medical evaluation or signed waiver to obtain either category of hearing aids is no longer required by federal law, as 21 CFR 801.421 was repealed. However, the federal rule authorizes states to maintain existing state laws or regulations that require a medical evaluation or signed waiver.
IMPLICATIONS FOR PRACTICE
All existing Nevada laws and regulations in NRS Chapter 637B and NAC Chapter 637B remain in effect in relation to prescription hearing aids, except as indicated below where federal law takes precedence over state law:
Section
Section Title
Summary
Status After Final Rule
Impact on Practice
NRS 637B.242
Sale of hearing aids by catalog, mail or Internet: Conditions; records; regulations.
Requires a licensee to obtain a medical evaluation or waiver when selling hearing aids by catalog, mail, or Internet.
REMAINS IN EFFECT
Licensees must still obtain a medical evaluation or waiver ONLY WHEN selling hearing aids by catalog, mail, or Internet.
NRS 637B.250(2)(d)(1)
Grounds for Initiating Disciplinary Action
Includes a violation of
21 CFR 801.421 as grounds for disciplinary action.
NO LONGER
APPLICABLE
21 CFR 801.421 no longer exists, so a violation of the rule could not be considered grounds for disciplinary action.
NAC 637B.0444
Requirements concerning waiver by client of medical evaluation.
Describes requirements for obtaining a waiver of
medical evaluation.
CONDITIONALLY
APPLICABLE
NOT APPLICABLE to in-person hearing aid fitting and dispensing.
APPLICABLE to sales of hearing aids by catalog, mail, or Internet.
(per NRS 637B.242 above)
NAC 637B.045
Preparation and retention of health care records and other records.
Requires waiver of medical evaluation to be included
in patient records.
OTHER RESOURCES
The Board’s laws and regulations, including this guidance are available on the Board website.
Additionally, the Board has adopted and posted guidance on OTC hearing aids for consumers and the public.
Many of the Board’s partners, including the American Academy of Audiology (AAA), American Speech-Language-Hearing Association (ASHA), and the International Hearing Society (IHS) have created OTC Hearing Aid resources for practitioners.
Please contact the Board office at (775) 787-3421 or [email protected] if you have additional questions.
Thank you for your service to the citizens of Nevada.
Jennifer R. Pierce, Executive Director
Nevada Speech-Language Pathology, Audiology and Hearing Aid Dispensing Board
6170 Mae Anne Avenue, Suite 1, Reno, NV 89523
[email protected] | 775.787.3421
