Apple’s newly announced hearing aid feature is the first FDA-approved over-the-counter (OTC) hearing aid software. It should be available on devices soon.
The federal agency officially unveiled the tech giant’s new “Hearing Aid Features,” which the agency calls HAF, just days after the company held its keynote “Glowtime” event, which introduced a slew of new health features. HAF allows AirPods Pro users to take a personalized hearing test on their device, which can then be used to customize audio settings in hearing aid software, effectively turning the in-ear headphones into hearing aids.
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Apple announced the hearing aid model on September 10, noting that the company expected to receive federal approval “soon,” but the FDA acted faster than expected.
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Michelle Tarver writes: “Today’s marketing authorization for over-the-counter hearing aid software for a widely used consumer audio product is an important step in increasing the availability of hearing support for adults with mild to moderate hearing loss. Another step towards accessibility and acceptability.
The FDA approval also provides additional information on clinical testing of this feature. The FDA explained that Apple’s HAF was evaluated in a study that included “118 subjects with mild to moderate hearing loss at multiple sites in the United States.” “The results showed that subjects using the HAF adaptive fit strategy achieved similar perceptual benefits to subjects who received professional fit of the same device. The results also showed that tests measuring ear canal amplification levels, and the results of those measurements, were comparable. No adverse events related to the device were observed in this study.
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The feature’s consumer approval bolsters the agency’s recent new additions 2022 OTC Hearing Aid Regulationsallowing consumers “considered to have mild to moderate hearing impairment” to purchase hearing aids without first obtaining a physical exam, prescription or audiologist’s approval.
Hearing aid functionality will be available on compatible AirPods Pro devices in a future software update.
