In a groundbreaking move that could revolutionize both the technology for, and access to hearing aid devices, Apple announced at their September 9 event that the company’s Airpods Pro 2, released last year, will receive software this fall allowing the device to — once approved by the FDA — serve as an over-the-counter (OTC) clinical hearing aid. Just three days later the FDA gave the green light to Apple’s Hearing Aid Function (HAF) — their first approval for an OTC hearing aid software device.

Though the release date is unknown, an upcoming iOS update (18.1) is expected to roll out October 28 with a variety of new features including Apple Intelligence — and beta testers for the update (including this writer) have noted a placeholder for hearing health, suggesting the features may be activated alongside the update.

According to the NIH, about 15 percent of American adults report some trouble hearing — about 37.5 million, with 30 million reporting trouble hearing in both ears. As age increases, so does the prevalence of hearing loss: though just five percent of adults ages 45-54 have disabling hearing loss, that number doubles to 10 percent of those ages 55-64. This more than doubles to 22 percent of those ages 65-74. For those ages 75 and older, 55 percent have disabling hearing loss. Men are nearly twice as likely as women to have hearing loss.

Hearing loss is about more than meets the ear. Research from Johns Hopkins shows mild hearing loss doubles (and moderate hearing loss triples) dementia risk, increases walking problems and falls, and leads to social isolation linked to depression, heart disease, poor sleep, substance abuse, and other ailments.

The Over-The-Counter Hearing Aid Act of 2017 tasked the FDA with creating a new OTC category of hearing aids, which as of October 2022 are now available nationwide. OTC hearing aid devices are available to all adults 18 and over with perceived mild-to-moderate hearing loss, without restriction.

There are two categories of OTC hearing aids: legacy devices with only basic features such as volume control or preset programs, and new self-fitting devices (or, in Apple’s case, software paired with a compatible device) featuring greater customization using hearing tests, software, and smart device connectivity.

Dr. Travis Stehouwer, Au.D., audiologist with Hearing Doctors Falls Church, told the News-Press during an interview that the new technology Apple announced sounds exciting — and is certainly worth a shot at the price — but cautions we won’t know any details of how Apple plans to provide hearing assistance through its new software until its launch.

For those with severe hearing loss, Dr. Stehouwer says that there truly is no competition with prescription hearing aids; there are six or seven manufacturers that dominate the market, and they all – and their extensive research teams focused solely on hearing aid advancement – have been around for decades. They are pricey, though: the top hearing aids cost close to $7,000.

Though adding a hearing test and related calibration at this price point is a big step forward for OTC device quality, Dr. Stehouwer cautions that “if [the built-in hearing test] of the device does confirm hearing loss in a user, they still should get a true diagnostic hearing exam from an audiologist.” Audiologists like Dr. Stehouwer, he says, can visibly check your ears, interpret test results, and help determine the root cause(s) for, extent of, and most appropriate remedies to your hearing loss — things that an automated hearing test, no matter how advanced, cannot do — which is useful regardless of whether you end up using OTC or prescription hearing aids.

It appears Apple agrees: they claim users will be able to program audiogram information from a hearing specialist into the HAF for calibration. With most OTC hearing aids offering just preset modes or volume toggles, incorporating user-specific hearing test results into the actual calibration of the device — whether the built-in hearing test or a true diagnostic exam from an audiologist — could quickly put the Airpods Pro 2 in a league of their own, at one-quarter the cost of the nearest device offering a test and calibration options.

When you factor in the features of AirPods that already make them appealing to users — seamless integration to iPhone and Siri, high-quality audio and noise cancelation, an attractive design, and Apple’s extensive library of applications (making it possible to do anything from translate to transcribe in real-time) — the features listed for the AirPods Pro 2 hold their own against even the most premium OTC hearing aid devices.

Though the actual quality of the software’s features won’t be known until its release, the potential is there for Apple to revolutionize access to quality hearing assistance. To learn more or purchase Apple AirPods Pro 2, visit apple.com/airpods-pro.