Congress’ recent passage of the Over-the-Counter Hearing Aid Act of 2017 gives the U.S. Food and Drug Administration three years to officially create a new regulatory class of devices that can be purchased directly by consumers in drugstores or online. But already the FDA’s decision to stop enforcing rules requiring a medical evaluation and other restrictions for buying hearing aids is leading to cheaper, more innovative products.
San Leandro, Calif.-based company iHear Medical, for example, has just begun to sell a new FDA-approved hearing aid, the Eva, which is specifically designed for women. The device is scaled down to fit smaller female ear canals. Its sound processing uses algorithms tailored to women, who tend to lose low frequencies first, the opposite of men. A pair of the devices costs less than $800 — a fraction of the $2,363 average cost for a single prescription hearing aid, according to a 2015 federal report.
Adnan Shennib, iHear’s founder, said the Eva also eliminates the need to go to an audiologist’s office for calibration. Instead, Eva users get a separate device, also FDA approved, that can be attached to a laptop computer to test their hearing and program the hearing aid. The company’s hearing professionals also can program the device remotely. Shennib said the home test is the first to be approved by federal regulators.
Shennib said he hopes to make hearing tests as accessible as glucose monitoring, which now can be done at home.
Other companies, such as MDHearingAid and Audicus, also are selling devices directly to consumers online.
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