Comparison of hearing-aid effectiveness based on user-operated versus traditional audiometry: a randomised clinical trial.

Objective: To investigate whether hearing-aid fitting based on user-operated audiometry is non-inferior to hearing-aid fitting based on traditional audiometry.

Design: This non-inferiority randomised clinical trial, took place at Odense University Hospital, Odense, Denmark. In a first visit, participants were tested with traditional audiometry as well as user-operated audiometry and filled in the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at baseline. Next, they were randomly divided to receive hearing aids fitted based on either the user-operated (UAud group) or the traditional audiometry (control group) hearing thresholds. After three months of hearing-aid use, participants underwent an aided hearing-in-noise test and completed the SSQ12 again, as well as an additional battery of outcome measures.

Study sample: A total of 215 adults with sensorineural hearing impairment referred for bilateral hearing-aid fitting.

Results: The before-after change in SSQ12 total scores was not different between the groups as the interaction between test times and groups was -0.06 (95% CI -0.56 to 0.44, p = 0.811).

Conclusions: The findings suggest that the HA effectiveness in the UAud group was non-inferior to those observed in the control group. This implies that integrating user-operated audiometry into the clinical system is feasible, offering potential personnel time savings without compromising patient outcomes.

Trial registration: The trial was registered at ClinicalTrials.gov (NCT05043207).