Quantifying the Benefits and Cost-effectiveness of Real-Ear Measurements (REM) for Hearing Aid Fitting
Key facts
- Who runs it
- Kuopio University Hospital
- Where
- Finland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 101 people enrolled
- Started
- 7 Sept 2022
- Ended
- 12 Sept 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Hearing Aid Manufacturer's Software
- REM (Real Ear Measurements)
- Record updated
- 4 March 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- 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
Who cannot take part
- confirmed cases of cognitive decline or dementia
- unilateral or conductive hearing impairment
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Hearing Aid Manufacturer's Software GroupExisting treatment, for comparison
Participants' hearing aids are fitted by using manufacturer's software.
Treatment: Hearing Aid Manufacturer's Software and REM (Real Ear Measurements)
- REM GroupExisting treatment, for comparison
Participants' hearing aids are fitted by REM (Real Ear Measurements) method.
Treatment: Hearing Aid Manufacturer's Software and REM (Real Ear Measurements)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 4 March 2026