Direct to Consumer & Over the Counter Hearing Aids
National Policy Updates
FDA Proposed Rulemaking
The purchase of hearing aids direct by consumer using the internet, in-person, without the involvement of a licensed and trained hearing healthcare professional, compromises outcomes and places consumers at risk of missed, and sometimes serious, medical pathology, or being improperly and/or inappropriately fitted with hearing devices. IHS strongly urges anyone who suspects they may have hearing loss to see a licensed professional - a hearing aid specialist or audiologist - to determine whether hearing aids can help or medical intervention may be necessary. IHS encourages providers and the public to review its best practices and position statement for further information.
IHS Best Practices for Fitting and Dispensing Hearing Aids
IHS Position Statement on Direct to Consumer Sales
In recent years, several workgroups and policymakers have taken steps to establish an over-the-counter hearing aid classification in order to meet the needs of individuals who require this approach to obtain hearing assistance. These efforts led to the passage of a new law in 2017, contained in PL 115-52, the FDA Reauthorization Act, Section 709, that directs the U.S. Food and Drug Administration to create an Over-the-Counter Hearing Aid classification.
How does PL 115-52 define an Over-the-Counter Hearing Aid?
- To be used by adults with perceived mild to moderate hearing loss
- The device may use wireless technology and include tests for self-assessing hearing loss
- The device may allow the user to control the hearing aid settings using tools, tests, or software
- Available over the counter in-person, by mail, or online without intervention of a licensed professional
The FDA was directed by Congress to include requirements in the final OTC hearing aid classification to:
- Provide “reasonable assurances” of the safety and effectiveness of the devices
- Establish output limits
- Address labeling, including statements/information regarding the intended users, adverse event reporting, indications of medically treatable causes of hearing loss, and advisements to consult promptly with a licensed practitioner
- Describe when OTC hearing aids may be sold without the involvement of a licensed professional
On October 20, 2021, FDA released: 1) Proposed rules for Over the Counter Hearing Aids; and 2) Draft Guidance "Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products." IHS shared IHS' Summary and Guidance on FDA Proposed Rules and Commenting for members and other stakeholders' use in developing and submitting comments ahead of the commenting deadline of January 18, 2022. Over 1,100 comments were submitted for the record on the proposed rules for Over the Counter Hearing Aids, which you can view via the Docket . Read IHS' comments on the proposed hearing aid rules and draft guidance . The FDA was granted six months to finalize the rules, and FDA staff indicated the final rule would go into effect 60 days after their release.