Over the Counter Hearing Aids
The Federal Drug Administration (FDA) regulates all hearing aids to ensure safety and effectiveness for consumers. In October 2022, the FDA enacted its Final Rule on Over the Counter (OTC) Hearing Aids, a monumental change that added a new classification of over-the-counter (OTC) hearing aids. Prior to the Final Rule, hearing aids could only be sold with a prescription.
This guidance was adpated from the FDA's OTC Hearing Aids: What You Should Know, and is intended to help patients, consumers, and licensees understand how this rule impacts Nevada's laws and regulations, ensure the safety and welfare of the public, and align practice with regulatory requirements.
Limitations on OTC Hearing Aids vs. Prescription / "Traditional" Hearing Aids
- Are defined by the FDA as as "air-conduction hearing aids that do not require implantation or other surgical intervention.
- May only be sold to adults 18 years of age and older to treat perceived mild to moderate hearing loss.
- Can be self-controlled and customized by the user with various tools, tests, or software.
- May come with wireless technology or tests for users to test their own hearing loss.
Types of OTC Hearing Aids
- Traditional and wireless hearing aids that may have basic features like volume control and preset programming.
- Self-fitting hearing aids (with or without wireless functionality) that may be customized using hearing tests, software, and smartphone apps.
- Apple AirPods Pro 2 have been approved as OTC hearing aid devices
Prescription (Traditional) Hearing Aids
- A prescription hearing aid is any hearing aid that is not an OTC hearing aid.
- Prescription hearing aids are only available through a licensed hearing health care professional who can program the device to your unique level of hearing loss.
- These devices may be appropriate for all levels of hearing loss and for all ages based on the indications for use.
Obtaining OTC Hearing Aids
- Are available to consumers over-the-counter without the supervision, involvement, or prescription of a licensed health care professional.
- May be purchased from a hearing clinic, in a store, or online without a medical exam, prescription, or a fitting adjustment by an audiologist or hearing aid specialist.
- If seen by an audiologist or hearing aid specialist, patients may request their hearing test records and buy hearing aids elsewhere.
- Before purchasing, consumers should make sure the outside package labeling on OTC hearing aids includes required information including the words "OTC" and "hearing aid", intended use, warnings & cautions, manufacturer contact information, return policy, condition (new or used), battery information, and control platform information explaining if/how a mobile device or other external platform is required to control the hearing aid.
Impact on Nevada Law
Still in Effect
- NRS 637B.250(2)(d)(1) Grounds for Initiating Disciplinary Action. This section includes a violation of 21 CFR 801.421 (repealed by the Final Rule) as grounds for disciplinary action. NRS 637B was revised in Assembly Bill 177 (2025) to include the current CFR reference.
No Longer in Effect
- NRS 637B.242 Sale of hearing aids by catalog, mail or Internet: Conditions; records; regulations. This section required a licensee to obtain a medical evaluation or waiver when selling hearing aids by catalog, mail, or Internet, but was repealed in Assembly Bill 177 (2025).
- NAC 637B.0444 Requirements concerning waiver by client of medical evaluation. This section required practitioners to obtain a waiver from a patient for a medical evaluation, but was repealed in in regulaoin revision XXXX
- NAC 637B.045 Preparation and retention of health care records and other records. This section required a waiver or medical evaluation to be included in patient records, but was pealed in regulaoin revision XXXX
Other Resources
- The Board’s laws and regulations, including this guidance are available on the Board website.
- 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 patients and practitioners