“Hearing Aid Feature” (HAF), the first OTC hearing aid software has received marketing authorisation by the FDA. Compatible headphones installed with this software serve as a hearing aid to amplify sounds for individuals with mild to moderate hearing impairment. Assistance of a hearing professional such as an audiologist is not required to customise the software/device to meet the hearing needs.
FDA has authorized the first over-the-counter (OTC) hearing aid software. Once installed and customized to the user’s hearing needs, the software enables compatible versions of the “Apple AirPods Pro” headphones to serve as a hearing aid to amplify sounds for individuals with mild to moderate hearing impairment.
Called “Hearing Aid Feature” (HAF), it is a software-only mobile medical application which is set up using an iOS device (e.g., iPhone, iPad). After setting up the software on compatible versions of the AirPods Pro, the users can adjust the volume, tone and balance settings from iOS HealthKit. Assistance of a hearing professional is not required to customise the software/device to meet the hearing needs.
The marketing authorisation for the OTC “Hearing Aid Feature” software to Apple Inc. was based on its clinical evaluation in a study at many sites in the USA. The study compared the “HAF self-fitting approach” with the professional fitting approach. The findings showed no adverse effects and the individuals in both the groups received similar perceived benefits in terms of sound amplification and speech understanding.
This development follows FDA’s OTC hearing aid regulations which came in force in 2022. This rule has empowered people with perceived mild to moderate hearing loss to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription or seeing an audiologist.
Hearing loss is a major public health problem worldwide. In the USA alone, over 30 million people suffer some degree of hearing loss. This condition is known to be associated with decline in cognition, depression and other health conditions among elderly people.
***
Sources:
- FDA News release – FDA Authorizes First Over-the-Counter Hearing Aid Software. Published 12 September 2024. Available at https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software
- Apple Press release – Apple introduces groundbreaking health features to support conditions impacting billions of people. Published on 09 September 2024. Available at https://www.apple.com/in/newsroom/2024/09/apple-introduces-groundbreaking-health-features/
***
