The 2017 Over the Counter Hearing Aid Act directed the FDA to create guidelines to allow retail stores to sell hearing aids as medical devices for mild to moderate hearing loss without a prescription. In October 2022, the FDA rules went into effect. Some of the same companies that previously sold heating assistance devices such as Nuheara and Bose applied for FDA clearance to market OTC hearing aids. San Jose-based medical company Eargo, Inc. began selling FDA Class II exempt Eargo 5 and Eargo 6 hearing aids in early 2022. This year at CES 2023, Eargo announced the Eargo 7 for OTC sales without a prescription.
Eargo models 5, 6, and 7 are self-fitting in-canal hearing aids. “Self-fitting” means you won’t need an audiologist to test, configure, and adjust the hearing aids. “In-canal” hearing aids fit partly or fully in the ear canal. According to a company news release, Eargo hearing aids are “virtually invisible.”
The latest model, the Eargo 7, brings new features and performance to the brand. Eargo’s Sound Adjust+ automatically optimizes the hearing aids’ settings for conversation, either emphasizing speech or using noise cancelation technology to reduce ambient sound. Whether or not you’re listening or talking, the Eargo 7 automatically reduces loud background noises. Many hearing assistance devices and hearing aids can adjust for speech and control ambient noise, but few even attempt to make the changes automatically.
Like the Eargo 6, the Eargo 7 is IPX7 water-resistance rated for immersion for up to 30 minutes in up to one meter of water. Eargo claims that all three models can run for up to 16 hours per change. The Eargo devices come with portable charging cases that can recharge the hearing aids for up to two days.
Eargo plans to ship the Eargo 7 in February for in 300 Best Buy stores and 1,500 Verizon stores. Eargo 7 hearing aids will cost $2,950 for a pair. Eargo 6 aids cost $2,650 and Eargo 5s are $1,950. The OTC act and FDA clearance for sales without prescriptions will boost the directly availability of these premium hearing aids.
