Quantifying the Benefits and Cost-effectiveness of Real-Ear Measurements (REM) for Hearing Aid Fitting

Status: Active_not_recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Adjusting hearing aid user's real ear performance by using probe-microphone technology (real ear measurement, REM) has been a well-known procedure that verifies whether the output of the hearing aid at the eardrum matches the desired prescribed target. Still less than half of audiologists verify hearing aid fitting to match the prescribed target amplification with this technology. Recent studies have demonstrated failures to match the prescribed amplification targets, using exclusively the predictions of the proprietary software. American Speech-Language-Hearing Association (ASHA) and American Academy of Audiology (AAA) have created Best Practice Guidelines that recommend using real-ear measurement (REM) over initial fit approach and also the recent ISO 21388:2020 on hearing aid fitting management recommends the routine use of REM. Still audiologists prefer to rely on the manufacturer's default first-fit settings because of the lack of proof over cost-effectiveness and patient outcome in using REM. There are only few publications of varying levels of evidence indicating benefits of REM-fitted hearing aids with respect to patient outcomes that include self-reported listening ability, speech intelligibility in quiet and noise and patients' preference. Our main research question is whether REM-based fitting improves the patient reported outcome measures - PROMs (SSQ, HERE) and performance-based outcome measures (speech-reception threshold in noise) over initial fit approach. An additional research question is whether REM-based fitting improves hearing aid usage (self-reported \& log-data report). Eventually, the investigators will calculate the cost-effectiveness of REM-based fitting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• all first-time adult patients (18-80 years of age) eligible for bilateral hearing aid rehabilitation based on an evaluation by an otolaryngologist or an audiologist

Locations
Other Locations
Finland
Kuopio University Hospital
Kuopio
Time Frame
Start Date: 2022-09-07
Completion Date: 2025-08-31
Participants
Target number of participants: 101
Treatments
Active_comparator: Hearing Aid Manufacturer's Software Group
Participants' hearing aids are fitted by using manufacturer's software.
Active_comparator: REM Group
Participants' hearing aids are fitted by REM (Real Ear Measurements) method.
Related Therapeutic Areas
Sponsors
Collaborators: Turku University Hospital
Leads: Kuopio University Hospital

This content was sourced from clinicaltrials.gov