Apple’s AirPods Pro 2: First Ever FDA-approved OTC Hearing Aid Technology

This month, Apple made history by gaining U.S. Food and Drug Administration (FDA) approval for a feature in the upcoming AirPods Pro 2. This feature is the first over-the-counter (OTC), clinical-grade hearing aid software. Referred to as the Hearing Aid Feature, this software is designed to amplify sound for adults experiencing mild to moderate hearing loss. It also includes a user-friendly hearing test, enabling users to assess their hearing capabilities easily.

A Game-Changer for Hearing Disabilities: Inclusivity in Technology

Hearing loss affects over 30 million American adults, leading to significant public health concerns. Factors contributing to hearing loss include aging, exposure to loud noises, certain medical conditions, and genetics. Untreated hearing loss can result in communication difficulties, social isolation, and increased risks of depression and cognitive decline. Research indicates that hearing aids can help mitigate these risks, enhancing quality of life for many individuals. As Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, stated, “Hearing loss is a significant public health issue impacting millions of Americans.”

The FDA’s OTC hearing aid regulations, established in October 2022, aimed to enhance access to safe and effective hearing aids. These regulations allow consumers to purchase hearing aids directly without requiring a medical exam or prescription. The newly authorized Hearing Aid Feature represents a significant step toward increasing the availability of hearing support for adults. This development aligns with efforts to make healthcare solutions more accessible, particularly for underserved populations.

Features of the Hearing Aid Software: iOS Personalization 

The Hearing Aid Feature (HAF) operates as a software-only mobile application compatible with AirPods Pro. Users can customize the HAF to meet their hearing needs without professional assistance. Set-up occurs via an iOS device, utilizing the iOS HealthKit to access users’ hearing levels for personalization. This self-fitting capability empowers individuals to manage their hearing health in a convenient and user-friendly manner.

In clinical evaluations involving 118 participants, the HAF demonstrated efficacy comparable to traditional professional fittings. Subjects using the HAF reported similar perceived benefits, with no adverse events recorded during the study. The results indicated that the self-fitting strategy effectively amplified sounds and improved speech understanding in noisy environments. This finding supports the potential of self-fitting technologies in hearing aid solutions, offering an alternative for those who may not have access to traditional audiological services.

Innovating for Better Hearing: Addressing Public Health Challenges

The HAF offers a self-fitting strategy that allows users to adjust volume, tone, and balance settings based on their preferences. According to Sumbul Ahmad Desai, Apple’s vice president of health, “Your AirPods Pro are transformed into a personalized hearing aid, boosting the specific sounds you need in real time.” This feature allows users to conduct a simple five-minute hearing test at home, which further personalizes their auditory experience.

While the OTC hearing aids, including Apple’s offering, primarily benefit individuals with mild to moderate hearing loss, they may encourage earlier intervention for those hesitant to seek traditional solutions. Meredith Resnick from the Hearing Loss Association of America expressed hope that such innovations will increase awareness and reduce stigma surrounding hearing loss. Resnick noted that “OTC hearing aids won’t be for everyone, but we hope they help some adults with mild-to-moderate hearing loss take a first step towards treatment sooner.”

The introduction of the HAF also highlights the importance of innovation in addressing public health challenges. As more companies explore technology-driven solutions for hearing loss, the potential for widespread adoption increases. The ability to purchase hearing aids without prescriptions can significantly reduce costs, making essential devices more accessible.

Normalizing Assistive Technology & the Role of Medical Professionals

Haben Girma, the first deafblind graduate of Harvard Law School, expresses optimism about AirPods Pro 2. She views them as a transformative tool for individuals with hearing disabilities. Girma emphasizes accessible technology, stating, “The diversity within this community includes a variety of different types of hearing and life experiences.” While Apple’s innovations offer new options, she highlights that medical professionals remain crucial. Many users may still need guidance after taking Apple’s hearing test.

Furthermore, Girma underscores Apple’s role in normalizing assistive technology. By integrating hearing aid features into everyday products like AirPods, Apple challenges the stereotype that disability tech must be unattractive or cumbersome. She asserts that “disability tech can be absolutely delightful.” These innovations often benefit everyone, not just those with disabilities. Additionally, Girma advocates for expanding opportunities for disabled individuals in tech. She urges companies to hire more engineers and designers with disabilities. This combination of innovative technology and professional support can empower users to make informed decisions about their hearing health, ultimately enhancing their quality of life.

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Author

Bernice Lottering