Prescription hearing aids fitted by audiologists provide patients with “significantly better outcomes” than over-the-counter (OTC) versions, according to a randomised clinical trial performed in America.
Results suggested that while lower cost OTC models, and OTC+ devices where audiologists provided limited services for OTC hearing aids, were both effective, the best outcomes were achieved with audiologist-fitted prescription hearing aids where practitioners followed the best practice service model.
The authors said their trial in 245 participants with mild to moderate hearing loss, mean age 67, introduced new insights which showed the audiologist fitted prescription devices outperformed OTC devices.
“The service model in which audiologists fitted prescription hearing aids (HAs) following best practices yielded significantly better outcomes compared with two over-the-counter (OTC) service models, although both OTC models still produced generally positive results,” they said.
Findings were published in JAMA Otolaryngology–Head & Neck Surgery online on 15 May 2025.
Participants who wore audiologist-fitted prescription hearing aids also reported higher satisfaction than those who wore OTC devices.
And those with audiologist-fitted prescription hearing aids were also 2.5 to 3.25 times more likely to wear their hearing aids all the time than those with OTC devices.
“We found no evidence suggesting that OTC+ was superior to OTC, indicating that the limited services provided in OTC+ did not enhance outcomes,” they said
“The study audiologists observed that when OTC+ participants faced device-related issues, such as acoustic feedback, the available solutions (eg, switching presets) were often insufficient to resolve the problems. Optimal outcomes may require more in-depth services, including probe-microphone measures, and greater flexibility in configuring devices using fitting software.”
Service counts
For the same generation of HAs, high-end and low-end devices yielded similar general patient-reported outcomes in clinical settings.
“The finding that the audiologist fitted prescription devices outperformed OTC (ones) raises an important question: was the outcome difference driven by the service itself, the participant’s personal interactions with audiologists, or both?” they asked.
“While our RCT could not directly address this, evidence suggests that the outcome difference was primarily driven by the service itself.”
The study also found that high-end and low-end hearing aids yielded similar outcomes, with authors claiming support for the higher costs of high-end hearing aids was not identified for individuals with mild to moderate hearing loss.
“Consistent with previous clinical trials, we did not find that high-end HAs provided better outcomes than low-end HAs,” they said.
“However, it is essential to clarify that many current low-end HAs incorporate technologies that were considered advanced in earlier generations, and our study did not compare devices across different generations. Therefore, our results should not be interpreted as implying that HA technologies do not improve patient outcomes.”
The authors were Dr Yu-Hsiang Wu and audiologist Dr Elizabeth Stangl from the University of Iowa’s Department of Communication Sciences and Disorders, audiologist Dr Kjersten Branscome and Professor Todd Ricketts from Vanderbilt University Medical Center’s Department of Hearing and Speech Sciences, and Professor Jacob Oleson from the University of Iowa’s Department of Biostatistics.
They conducted the trial at the University of Iowa and Vanderbilt University Medical Center in research laboratories from February 2019 to December 2023.
They included adults older than 55 years with mild to moderate hearing loss and no previous HA experience who were randomly assigned to one of six parallel groups, representing factorial combinations of three service models and two technology levels.
The trial included three service models: AUD, in which audiologists fitted prescription HAs following best practices; OTC+, in which audiologists provided limited services for OTC HAs; and OTC, in which participants independently used OTC HAs.
Two behind-the-ear prescription HA models (one high end about A$6,868 per pair) and one low end (about $1,717 per pair) were used, both from the same manufacturer.
OTC HAs were simulated using prescription HAs. Two models of prescription HAs were used: a high-end HA with advanced features and a low-end HA.
The primary outcome measure was the Glasgow Hearing Aid Benefit Profile (GHABP), which was administered using ecological momentary assessment (EMA). EMA-GHABP was conducted preintervention and throughout the seventh week postintervention.
Results
After controlling for preintervention scores, the postintervention EMA-GHABP global score (ranging from one to five) for AUD was significantly higher (indicating better outcomes) than for OTC+ and OTC by 0.33 points and 0.32 points, respectively.
The difference between OTC+ and OTC was not significant but EMA-GHABP global scores for OTC+ and OTC were close to four points, indicating positive outcomes. The effect of technology level and interaction between service model and technology level were not significant.
Study limitations included using only one preset-based OTC device by simulation, which authors said may not have captured the variability and range of OTC HAs available on the market. And because participants were randomly assigned to intervention groups, the OTC participants may not have represented clinical OTC HA users, who tend to be younger and report milder hearing difficulties compared with prescription HA users.
“We found no evidence suggesting that OTC+ was superior to OTC, indicating that the limited services provided in OTC+ did not enhance outcomes. The study audiologists observed that when OTC+ participants faced device-related issues, such as acoustic feedback, the available solutions (eg, switching presets) were often insufficient to resolve the problems. Optimal outcomes may require more in-depth services, including probe-microphone measures, and greater flexibility in configuring devices using fitting software.”
