The Hearing Industries Assn. conveyed its concerns with the FDA’s approval of Bose Corp.’s self-fitting hearing aid.
In October 2018, the FDA granted Bose de novo clearance for the over-the-counter device billed as the first of its kind on the U.S. market, according to the FDA’s Center for Devices & Radiological Health.
In a May letter to the FDA obtained by MedTech Dive, HIA urged the FDA to take into consideration the requirements for hearing aids intended for users with mild to moderate hearing loss without the involvement of a licensed hearing care professional.
HIA contended that the Phase II clinical study that helped secure the FDA’s approval was flawed and did not “provide enough evidence of effectiveness of the self-fitting method given the study’s initial reliance on professionals for fitting.”
The letter also noted that subjects in the clinical study were fit professionally during the first two of three clinic visits, which contradicts the “self-fitting” label of the device and “does not reflect the actual real-world experience.”
Other notes in the letter mentioned that the self-fit group in the clinical trial consisted of users almost three times more experienced (relative to new hearing aid users) than the pro-fit group. Finally, HIA wrote that the adoption of standards designed for amplification quality control purposes that don’t provide protections could “adversely impact safety and effectiveness and would jeopardize the hearing health of consumers who purchase these devices.”
Bose has not yet brought the device to market, a company spokesperson said the FDA’s decision “speaks for itself,” MedTech Dive reported.
