Apple AirPods Pro Receives FDA Approval for Over-the-Counter Hearing Aid Feature

Apple shares gained on 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.

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.

The FDA stated that 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.” This approval marks the first time that a hearing aid product can be purchased over-the-counter.

One of the notable features of the Hearing Aid Feature is its self-fitting capability, allowing patients to adjust it themselves after setting it up with an iOS device such as an iPhone or iPad. In a clinical study involving 118 subjects with perceived mild to moderate hearing loss, the HAF achieved similar perceived benefits as subjects who received professional fitting of the same device.

More Than 30 Million US Adults Have Some Hearing Loss

According to the FDA, more than 30 million American adults have some degree of hearing loss. This approval by the FDA is seen as a significant step in advancing the availability, accessibility, and acceptability of hearing support for adults with perceived mild to moderate hearing loss.

Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, expressed her enthusiasm for the decision, stating that it is 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% on Friday afternoon, have seen a year-to-date increase of about 16%.

For more information, read the original article on Investopedia.