FDA granted Bose's self-fit hearing aid a De Novo in 2018 based on clinical studies of 125 patients examining if the outcomes of self-fitting the device were comparable to professional fitting. The device is indicated direct-to-consumer sale to those over 18 without the assistance of an audiologist.
HIA's letter to Srinivas Nandkumar, the branch chief of FDA's Division of Ophthalmic and Ear, Nose, and Throat Devices, argues the Phase II clinical study "does not provide enough evidence of effectiveness of the self-fitting method given the study's initial reliance on professionals for fitting."
According to FDA's decision summary, the two-arm study of 75 patients had three clinic visits alongside several weeks of use in the real world. During the first two visits, patients were fit professionally by audiologists before being assigned to a one-month field trial in a professional fit group or self-fit group.
During the third visit, patients were accessed using speech-in-noise tests and questionnaires about the benefit of the devices.
"This does not reflect the actual real-world experience," HIA's letter states. "As such, HIA has concerns the data the study relies upon may not accurately reflect the ability of treatment-naive hearing patients to adequately 'self-fit' without the assistance of a licensed hearing professional."
Bose declined to elaborate on the specific concerns raised by HIA, pointing to FDA's determination the device is safe and effective.
"Our submission to the FDA for the De Novo grant, which we received last fall, speaks for itself," Bose spokesperson Joanne Berthiaume told MedTech Dive.
FDA declined to comment on the specific HIA letter but noted the De Novo pathway is intended to provide a path to market for medical devices when general and/or special controls can provide a reasonable assurance of safety and effectiveness.
"The Bose company submitted, and FDA granted, a request for De Novo classification," an FDA spokesperson told MedTech Dive in an email. "These decisions are based on a benefit vs risk decision making that is outlined in our publicly available decision summary."
HIA declined an interview with MedTech Dive, but its letter makes it clear it is attempting to influence over-the-counter hearing aid regulations under development.
HIA spent $30,000 during the second quarter lobbying Congress over the regulation of hearing aids and over-the-counter hearing aid devices. Brandon Sawalich, the chairman of the trade group's board of directors, is also the president of Starkey Hearing Technologies, a hearing aid firm that also heavily lobbies the government to protect its bottom line.
The FDA Reauthorization Act of 2017 mandates the agency establish a category of over-the-counter hearing aids by August 2020. The agency plans to issue a proposed rule in November that is intended "to promote the availability of additional kinds of devices that address age-related hearing loss," according to FDA's spring regulatory plan.
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