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A new randomized clinical trial published today in JAMA Otolaryngology–Head & Neck Surgery offers the most comprehensive comparison yet of how different hearing aid delivery models stack up. The study compared three service models—traditional audiologist-fitted (AUD), over-the-counter (OTC), and a hybrid model with limited professional support (OTC+)—and found that although all three approaches led to generally positive outcomes, patients fitted by audiologists consistently experienced better results.
For a healthcare system grappling with cost and access issues, the findings provide timely insight: OTC and hybrid models may help expand reach and affordability, but they do not fully replicate the benefits of professionally administered care.
Led by Yu-Hsiang Wu, MD, PhD, at the University of Iowa and Todd Ricketts, PhD, at Vanderbilt University Medical Center, the study involved 245 adults aged 55 to 85 years with mild to moderate bilateral hearing loss who had no prior experience with hearing aids. Over a 5-year period, the researchers studied the responses of randomly assigned participants in 6 groups, which represented three service models (AUD, OTC+, and OTC) and two technology levels (high-end vs. low-end hearing aids).
The hearing aids used in the study were real-world prescription devices from a single manufacturer, with retail values of approximately $4,400 (high-end) and $1,100 (low-end) per pair. In the OTC and OTC+ groups, these devices were modified to simulate preset-based OTC hearing aids with 4 gain/frequency response options (ie, not “self-fitting” hearing aids tailored to the individual’s specific hearing loss). All participants were followed for 7 weeks post-fitting, and the primary outcome was measured using the Ecological Momentary Assessment (EMA) version of the Glasgow Hearing Aid Benefit Profile (EMA-GHABP)—a smartphone-based, in-situ self-report tool designed to reduce recall bias.
Patients in the audiologist-led (AUD) group reported significantly better outcomes than those in the OTC or OTC+ groups. After adjusting for baseline scores, the EMA-GHABP global score for the AUD group was 0.32 to 0.33 points higher (on a 1-5 scale), exceeding the study's predefined threshold for a clinically meaningful difference of 0.3 points.
Dr. Wu told HearingTracker, “The difference in EMA-GHABP between AUD and OTC/OTC+ is around 0.33, which may seem small in absolute terms. However, given that the range of EMA-GHABP is 4 points (from 1 to 5), a 0.33 difference represents an 8.25% change. This is actually quite similar to the clinically meaningful difference in the APHAB; the late Dr. Robyn Cox, who created the APHAB scale, has stated that a 5% to 10% difference in APHAB scores is clinically meaningful.”
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Hearing aid usage also varied by delivery model: AUD participants were more likely to report wearing their devices “all the time” compared to OTC+ and OTC users. However, the study found no statistically significant difference between the OTC+ and OTC groups on any primary or secondary outcomes, including satisfaction, speech recognition in noise, and hearing handicap.
Notably, the technology level of the hearing aids made no difference. Participants using high-end hearing aids fared no better than those using low-end models, echoing prior research showing that, when audiologists used best practices, there were few substantial differences in outcomes between low and high tech levels.1,2
“Although we—and previous research—did not find evidence supporting the benefits of high-end hearing aids compared to low-end models, this does not mean that hearing aid technology has no real effect on real-world outcomes,” says Wu. “This is similar to the situation prior to our study, where no previous research had found evidence supporting AUD over OTC. Perhaps in the future, more sensitive outcome measures can be used to capture the real-world benefits of high-end hearing aids.”
The study builds on earlier randomized controlled trials conducted by researchers such as those led by Drs. Larry Humes and Karina De Souza and colleagues.3,4 It adds a new twist with its use of EMA—a method that captures self-reported experiences as they occur, rather than relying on retrospective memory. This likely accounts for the stronger evidence favoring the audiologist-led model, even in the absence of differences on lab-based tests like the Connected Speech Test (CST).
Interestingly, the hybrid OTC+ model—which added limited audiologist support to the OTC experience—did not yield better outcomes than OTC alone. Researchers speculated that this may be due to constraints in the level of service provided: 30-minute fittings and limited follow-ups were insufficient to address issues like feedback or poor acoustic fit, which typically require more hands-on care. This is a particularly interesting finding because telecare support has been considered by consumer resources, such as HearingTracker, when assessing the quality of over-the-counter (OTC) hearing aids. However, it’s essential to note that this study did not utilize the telecare support services of an actual OTC hearing aid company.
"The result suggests that the limited service in the OTC+ group did not impact the outcomes we measured in the study; however, this does not mean that OTC+ had no positive effects,” says Wu. “For example, we recently analyzed another piece of the data from this clinical trial to examine the effects of service models and hearing aid technology on 'hearing aid skills'. The results showed that participants in the AUD group had significantly better hearing aid skills than those in the OTC group. Similarly, the OTC+ group outperformed the OTC group. But no significant difference in hearing aid skills was observed between the AUD and OTC+ groups. Therefore, although the OTC+ service was limited, it was still beneficial in enhancing hearing aid skills. This benefit, however, did not translate to—or was not captured by—the outcomes we measured in this study.”
In a previous study, the authors investigated whether a personal relationship with an audiologist could be a contributing factor to the improved outcomes in the AUD group.5 They concluded that it's the quality and comprehensiveness of the fitting protocol—not just rapport—that drives results.
The present study has several limitations. It tested only a simulated OTC device, excluded experienced hearing aid users, and did not examine an actual FDA-cleared self-fitting OTC product that offers telecare support. Additionally, the trial was not powered to detect interaction effects between service model and technology level, so those analyses should be interpreted with caution.
This study confirms that although OTC and hybrid service models can deliver broadly positive outcomes for new hearing aid users, the gold standard remains audiologist-led care. Patients who received full-service fittings from audiologists are more likely to wear their hearing aids consistently and report better hearing-related quality of life.
"For me, the most interesting finding is that we showed AUD outperformed OTC,” says Wu. “Previous studies have suggested no difference between AUD and OTC. Although I am a strong supporter of OTC, the findings that AUD and OTC produce the same patient outcomes make no sense to me. I firmly believe that the tool used to measure outcomes matters [i.e., EMA vs. retrospective questionnaires].”
The study also supports previous research that raises questions about the value proposition of high-end hearing aid technology for this population. High-end hearing aid features may offer perceptual or situational advantages, but these benefits have not translated into significantly improved outcomes using current measurement tools, which may lack the granularity to detect nuanced improvements.
Original article citation: Wu YH, Stangl E, Branscome K, Oleson J, Ricketts T. Hearing aid service models, technology, and patient outcomes: A randomized clinical trial. JAMA Otolaryng-Head Neck Surg. 2025; doi:10.1001/jamaoto.2025.1008
Karl Strom ist der Chefredakteur von HearingTracker. Er war Gründungsredakteur von The Hearing Review und berichtet seit über 30 Jahren über die Hörhilfenindustrie.
