The FDA on Tuesday issued a rule approving the sale of over-the-counter hearing aids. The move could save consumers thousands of dollars and also opens the door for increased competition. In anticipation of Agency approval, companies such as Bose have been developing new products that will not only be less expensive but perhaps also more effective than existing devices.
The new rule means that U.S. consumers will be able to purchase hearing aids in stores or online without having a prescription or medical exam. FDA stated that approximately 30 million individuals suffer from hearing loss but only one-fifth seek help. The new rule will upend the market by providing more affordable devices and driving technological innovation similar to that seen in today’s smartphones.
The rule becomes effective October 17, 2022, giving manufacturers and distributors a chance to comply with certain labeling and other requirements.