FDA Approves First-Ever OTC Hearing Aid Software

The FDA has authorized the first OTC hearing aid software, Hearing Aid Feature (HAF), according to an agency release.¹ Designed for Apple AirPods Pro headphones, this medical application allows compatible models to function as hearing aids for adults aged 18 and older with mild to moderate hearing loss. Users can benefit from amplified sounds tailored to their specific needs after installation and personalization.

“Hearing loss is a significant public health issue impacting millions of Americans,” said Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, in the release.¹ “Today’s marketing authorization of an OTC hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”

The HFA uses a self-fitting process that allows users to adjust settings without help from a hearing professional. Users’ hearing levels are assessed from the iOS HealthKit, and after initial setup, users can fine-tine volume, tone, and balance to meet their specific needs.

The FDA’s authorization is supported by a clinical study involving 118 subjects with perceived mild to moderate hearing loss at multiple US sites. The results demonstrated that participants who used the HAF self-fitting strategy achieved similar perceived benefit as participants who received professional fitting of the same device.¹

Additionally, results demonstrated comparable performance for tests measuring levels of amplification in the ear canal and as a measure of speech understanding in noise.¹ No adverse events related to the device were observed in the study.

The HAF was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

READ MORE: Abbott’s OTC Lingo CGM for Wellness Now Available

Over 30 million American adults experience some hearing loss, yet only about one-fifth of those who could benefit from hearing aids seek help.²

Hearing loss can result from aging, exposure to loud noises, medical conditions, and other factors, and can negatively impact communication, relationships, work or school performance, and emotional well-being. Studies have shown that using hearing aids can reduce the frequency or severity of cognitive decline, depression, and other health issues in older adults.¹

Congress passed bipartisan legislation in 2017 requiring the FDA to establish a category of OTC hearing aids, but full implementation didn’t occur until October 2022. Now, these regulations allow consumers with mild to moderate hearing loss to purchase hearing aids directly from stores or online retailers without needing a medical exam, prescription, or audiologist appointment.³ This represents a significant step towards ensuring greater access to safe and effective hearing aid options for the patient population.

The HAF will be able to be paired to iOS devices following a free software update, as revealed at Apple’s recent “Glow Up” event.⁴

READ MORE: OTC Resource Center

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References

1. FDA authorizes first over-the-counter hearing aid software. News release. FDA. September 12, 2024. Accessed September 13, 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software?utm_medium=email&utm_source=govdelivery

2. OTC hearing aids: What you should know. Fact sheet. FDA. Accessed September 13, 2024. https://www.fda.gov/medical-devices/hearing-aids/otc-hearing-aids-what-you-should-know

3. FDA finalizes historic rule enabling access to over-the-counter hearing aids for millions of Americans. News release. FDA. August 16, 2022. Accessed September 13, 2024. https://web.archive.org/web/20221028042729/https:/www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans

4. Aquino S. Apple’s ‘It’s Glowtime’ special event put an appreciably vivid glow on accessibility. Forbes. September 11, 2024. Accessed September 13, 2024. https://www.forbes.com/sites/stevenaquino/2024/09/11/apples-its-glowtime-special-event-put-an-appreciably-vivid-glow-on-accessibility/