Self-fitted over-the-counter (OTC) hearing aids may be an effective option for individuals with mild to moderate hearing loss, a small randomized effectiveness trial reports. OTC devices yielded 6-week patient-perceived and clinical outcomes comparable to those with audiologist-fitted hearing aids, In fact, at week 2, the self-fitted group had a small but meaningful advantage on two of the four study outcome measures.
“After support and fine-tuning were provided to the self-fitting (remote support) and audiologist-fitted groups, no clinically meaningful differences were evident in any outcome measures at the end of the 6-week trial,” wrote researchers led by Karina C. De Sousa, PhD, a postdoctoral researcher in the department of speech-language pathology and audiology at the University of Pretoria, South Africa.
Dr. De Sousa
Dr. Karina C. De Sousa
Their findings appear in JAMA Otolaryngology–Head & Neck Surgery.
Hearing aid uptake is low even in populations with adequate access to audiological resources, the authors noted, with hearing aid use in U.S. adults who could benefit estimated at about 20%. Currently, an estimated 22.9 million older Americans with audiometric hearing loss do not use hearing aids.
Major barriers have been access and affordability, Dr. De Sousa and associates wrote, and until recently, people with hearing loss could obtain hearing aids only after consultation with a credentialed dispenser. “The World Health Organization estimates that over 2.5 billion people will experience some degree of hearing loss by 2050,” Dr. De Sousa said in an interview. “This new category of self-fitting hearing aids opens up newer care pathways for people with mild to moderate hearing loss.”
The study
From April to August 2022 the trial recruited 68 participants (51.6% men) with mild-to-moderate self-reported hearing loss, a mean age of 63.6 years, and no ear disease within the past 90 days. They were randomized to a self-fitted commercially available device (Lexi Lumen), with instructional material on set-up and remote support, or to the same unit fitted by an audiologist. The majority in both arms were new users and were similar in age and baseline hearing scores.
The primary outcome measure was patient-reported hearing aid benefit, measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. This scale evaluates auditory acuity before and after amplification by such criteria as ease of communication, background noise, reverberation, aversiveness, and global hearing status.
Secondary measures included the International Outcome Inventory for Hearing Aids (IOI-HA) and speech recognition in noise measured using an abbreviated speech-in-noise test and a digits-in-noise test. Measures were taken at baseline, week 2, and week 6 after fitting. After the 2-week field trial, the self-fitting arm had an initial advantage on the self-reported APHAB: difference, Cohen d = −.5 (95% confidence interval [CI], −1.0 to 0). It also fared better on the IOI-HA: effect size, r = 0.3 (95% CI, .0 to –.5), but not on speech recognition in noise.
One member of the self-fitting arm withdrew owing to an unrelated middle-ear infection.
“While these results are promising, it is essential to note that OTC hearing aids are not a one-size-fits-all approach,” Dr. De Sousa said. “If a person has ear disease symptoms or hearing loss that is too severe, they have to consult a trained hearing health care professional.” She added that proper use of a self-fitted OTC hearing aid requires a degree of digital proficiency, as many devices are set up using a smartphone.
This study was supported by the National Institutes of Health and by the hearX Group, which provided the Lexie Lumen devices and software support for data collection. Dr. De Sousa reported nonfinancial support from hearX as well as consulting fees from hearX outside of the submitted work. A coauthor reported grant support from the UK’s National Institute for Health and Care Research Manchester Biomedical Research Centre, and fees from hearX during and outside of the study. Another coauthor disclosed fees, equity, and grant support from hearX during the conduct of the study.