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Key Takeaways
- An over-the-counter (OTC) hearing aid software device for use in Apple AirPods Pro has been approved by the Food and Drug Administration.
- The Hearing Aid Feature is the first time such a product can be purchased OTC.
- The FDA said the Hearing Aid Feature can be adjusted by the patient.
Apple (AAPL) shares gained Friday as the Food and Drug Administration (FDA) approved the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature (HAF), for use in the tech giant’s AirPods Pro.
The FDA said when the HAF is installed and customized to the user, it will help “amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.”
Officials noted that the HAF is self-fitting, and patients can adjust it by themselves after setting it up with a iOS device such as an iPhone or iPad. It added that in a clinical study of 118 subjects with perceived mild to moderate hearing loss, HAF achieved similar perceived benefit as subjects who received professional fitting of the same device.
More Than 30M US Adults Have Some Hearing Loss
According to the FDA, more than 30 million American adults have some degree of hearing loss.
Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, called the decision “another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”
Shares of Apple, which rose less than 1% Friday afternoon, are up about 16% year-to-date.