Dive Brief:
- The Food and Drug Administration said Thursday it authorized a hearing aid feature for certain versions of Apple’s Airpods Pro earbuds.
- Apple applied via the de novo premarket review pathway and is the first company to receive authorization for over-the-counter hearing aid software. The company disclosed its plans to add hearing aid capabilities to its earbuds on Monday.
- The authorization comes almost two years after FDA regulations allowed hearing aids to be sold without a prescription to people with mild to moderate hearing loss. Initially, companies focused on hardware, but the Apple authorization creates a predicate for other businesses that want to launch hearing aid software for existing products.
Dive Insight:
Apple applied for de novo authorization in December. The company validated the technology in a study that enrolled 118 people with perceived mild to moderate hearing loss at multiple U.S. sites.
Participants who self-fitted Apple earbuds achieved similar perceived benefits as people who had the same devices fitted by professionals. Measures of amplification and speech understanding were comparable as well.
The FDA identified physical discomfort, worsening hearing because of high volumes, insufficient sound amplification leading to ineffective treatment and poorer than expected patient outcomes and missed or delayed treatment as potential risks of the software. The administration has outlined mitigation measures for each of the risks.
Guided by the risks, the FDA has created special controls for air-conduction hearing aid software such as Apple’s new earbud technology. Companies that want to bring similar software to market via the 510(k) pathway will need to validate self-fitting strategies using clinical performance data, show intended users can correctly operate the hearing aid and meet other special controls established by the FDA.
Apple targeted a fall launch date for the hearing aid capabilities when it unveiled the incoming feature earlier this week. Once the software is rolled out, Airpods Pro 2 users will be able to perform a pure-tone audiometry test to check their hearing at home and have their devices boost certain sounds based on the results.
The launch will create competition for the wave of companies that entered the OTC hearing aid market when the FDA changed its regulations in 2022. Sony and the Bose-partnered Lexie began selling devices for $999, while Lucid and HP rolled out cheaper products.
People ages 18 years and older will be able to use the devices to check their hearing when the software goes live.
Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health, said in a statement the software “advances the availability, accessibility and acceptability of hearing support.”
