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Introduction: In 2022, the US Food and Drug Administration enacted final regulations to establish the category of over-the-counter (OTC) hearing aids aimed at reducing barriers to access hearing health care for individuals with self-perceived mild to moderate hearing loss. However, given the infancy of this device category, the effectiveness of OTC hearing aids in real-world environments is not yet well understood. Methods and results: To gain insights into the perceived benefit of self-fitting OTC hearing aids, a two-pronged investigation was conducted. In the primary investigation, 255 active users of a self-fitting OTC hearing aid were surveyed on their perceived benefit using an abridged form of the Satisfaction with Amplification in Daily Living (SADL) scale. The mean global (4.9) and subscale scores (Positive Effect (PE): 4.3; Negative Features (NF): 4.3; Personal Image (PI): 6.1) were within the range of those previously reported for users of prescription hearing aids. In the secondary investigation, 29 individuals with self-reported hearing impairment but no prior experience with the investigational self-fitting OTC hearing aids used the devices and reported their perceived benefit and satisfaction following short-term usage. For this prospective group, the global SADL (5.4) and subscale scores (PE: 4.8; NF: 4.9; PI: 6.5) following a minimum of 10 weeks of real-world use were also within the range of those previously reported for traditional hearing aid users. In addition, this prospective group was also asked quality of life questions which assessed psychological benefits of hearing aid use. Responses to these items suggest hearing aid related improvements in several areas spanning emotional health, relationships at home and at work, social life, participation in group activities, confidence and feelings about one's self, ability to communicate effectively, and romance. Discussion: Converging data from these investigations suggest that self-fitting OTC hearing aids can potentially provide their intended users with a level of subjective benefit comparable to what prescription hearing aid users might experience.
RESUMO
OBJECTIVES: This study establishes research priorities for medically not yet explained symptoms (MNYES), also known as persistent physical symptoms or medically unexplained symptoms, from the perspective of patients, caregivers and clinicians, in a priority setting partnership (PSP) following the James Lind Alliance (JLA) approach. Research into such symptoms in general has been poorly funded over the years and so far has been primarily researcher-led with minimal input from patients, caregivers and clinicians; and sometimes has been controversial. DESIGN: JLA PSP method. The PSP termed these symptoms MNYES. METHODS: The study was conducted according to the JLA's detailed methodology for conducting priority setting exercises. It involved five key stages: defining the appropriate term for the conditions under study by the PSP Steering Group; gathering questions on MNYES from patients, caregivers and clinicians in a publicly accessible survey; checking these research questions against existing evidence; interim prioritisation in a second survey; and a final multi-stakeholder consensus meeting to determine the top 10 unanswered research questions using the modified nominal group methodology. RESULTS: Over 700 responses from UK patients, caregivers and clinicians were identified in the two surveys and charities contributed from a broad range of medical specialties and primary care. The final top 10 unanswered research questions cover, among others: treatment strategies, personalisation of treatment, collaborative care pathways, training for clinicians and outcomes that matter to patients. INTERPRETATION: The top 10 unanswered research questions are expected to generate much needed, relevant and impactful research into MNYES.
