Hearing Industry Calls Bose Self-Fit Hearing Aid Study Flawed in Complaint to FDA

The Hearing Industries Association (HIA) claimed that the U.S. Food and Drug Administration's (FDA) marketing authorization of Bose's self-fitting hearing aid is founded on a flawed clinical study design, reports MedTech Dive . The group warned the FDA's decision depends on standards that could "adversely impact safety and effectiveness and would jeopardize the hearing health of consumers." The study aimed to determine whether the results of self-fitting the Bose device were comparable to professional fitting. HIA said in a letter to FDA official Srinivas Nandkumar that 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." FDA's decision summary stated the study of 75 individuals involved three clinic visits alongside several weeks of real-world use, with subjects fit professionally by audiologists in the first two visits, before being assigned to a one-month field trial in a professional fit group or self-fit group. The third visit had participants accessed using speech-in-noise tests and questionnaires about the benefit of the devices. HIA said the study "does not reflect the actual real-world experience," raising issues that "the data the study relies upon may not accurately reflect the ability of treatment-naive hearing subjects to adequately 'self-fit' without the assistance of a licensed hearing professional."