An interventional study of Hearing Aid Manufacturer's Software and REM (Real Ear Measurements) in Sensorineural Hearing Loss, Bilateral, sponsored by Kuopio University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Kuopio University Hospital · Not applicable, Interventional, and Supportive care
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.
Adjusting hearing aid user's real ear performance by using probe-microphone technology (real ear measurement, REM) has been a well-known procedure over 30 years among audiologists. With this measurement technique, it is possible to verify whether the output of the hearing aid at the eardrum matches the desired prescribed target. Still less than half of audiologists verify their hearing aid fitting to match the prescribed target amplification with this technology. Many still rely on the manufacturer's default "first-fit" settings (initial fit approach) which means that the patient's hearing thresholds at any given frequency are transferred to the programming software that predicts the output and gain of the hearing aid by using proprietary or modified prescriptive algorithm. These proprietary algorithms create an approximation over patients in situ hearing aid gain and output based on data such as the age of the patient, an estimate of microphone location effects, the ear mold or shell design and length, venting size, and tubing characteristics.
Recent studies have demonstrated failures to match the prescribed amplification targets, using exclusively the predictions of the proprietary software. The 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 in order to verify the prescribed gain and output of the hearing aids. Accordingly, the recent ISO 21388:2020 on hearing aid fitting management recommends the routine use of REM. So why is REM still rarely applied clinically? The main reason is the lack of proof over cost-effectiveness and patient outcome. 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. According to a very recent systematic review and meta-analyses by Almufarrij et al. published in 2021, there are only six publications that meets the inclusion criteria, and the evidence favors REM fitting for all outcomes reported (self-reported listening ability, speech intelligibility in quiet and noise and preference). Still, the quality of evidence varies across the outcomes since all articles had a rather limited number of participants and only two used power calculation to determine the sample size. None of these studies reported health-related quality of life, which was assessed to be the primary outcome by the reviewers. Also, secondary outcomes of interest including adverse events, generic quality of life and cost-effectiveness were not assessed. The authors also acknowledged the lack of sufficient follow-up duration (the maximum duration was only 6 weeks) and the lack of permission for further adjustment to the amplification characteristics. In addition, the included studies failed to investigate first-time users over experienced hearing-aid users and the amplification characteristics the experienced users were familiar with, were not reported. This was judged to possibly impact on short-term outcomes since changes of hearing-aid users' amplification characteristics that they are already accustomed to, can cause discomfort. The authors also claimed that future studies should also estimate the importance of any benefit found and evaluate the reasons why participants are reporting these benefits.
In summary, current evidence indicates that the initial fit approach often fails to achieve the prescriptive acoustic gain and output of hearing aids, however, evidence which would clearly show that REM-based hearing aid fitting (which is time-consuming) is clinically relevant and cost-effective is lacking, and thus warrants further studies.
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. These are the primary outcomes of our study. 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. These are the secondary outcomes of our study.
371 studies on the registry are indexed under Hearing Loss, Sensorineural; 112 are open to participants now.
This study's enrollment of 101 is above the median of 32 across 264 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →Kuopio University Hospital is the lead sponsor of 132 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants' hearing aids are fitted by using manufacturer's software.
Other: Hearing Aid Manufacturer's Software · Other: REM (Real Ear Measurements)
Participants' hearing aids are fitted by REM (Real Ear Measurements) method.
Other: Hearing Aid Manufacturer's Software · Other: REM (Real Ear Measurements)
When using hearing aid manufacturer's software (s.c. "first-fit" or "initial fit") the fitting will follow the guided fitting procedure in the fitting software.
Participants' hearing aids are fitted by using REM. In this method REM measurement tube is placed inside participant's ear canal near the tympanic membrane and the Real Ear Unaided Gain (REUG) is measured. REUG is used to measure the ear canal without any hearing device and shows the patients ear acoustics. Next the hearing aid is placed on the patients ear together with the REM measurement tube. In REM measurements the Real-Ear Occluded Gain (REOG) is measured with the hearing aid off. REOG allows consideration of the attenuation caused by the earpiece and its obstructing effect of external sounds. Next Real Ear Aided Response (REAR) is measured with the hearing device on. REAR allows measurement of the hearing device's amplification effect within the patients' ear and includes the effect of the patient's ear acoustics.
Patient Related Outcome Measure: Speech, Spatial and Qualities of Hearing Scale (SSQ)
Participants are asked to fill out SSQ questionnaire during every clinical visit. This questionnaire includes 49 items with a numeric rating scale from 0 to 10 for each item and allows the assessment of hearing with and without hearing aids. Higher scores mean better outcome.
Time frame: Change measures: 0 months, 2 months, 4 months, 6 months.
Patient Related Outcome Measure: Hearing in Real-Life Environments (HERE)
Participants are asked to fill out HERE questionnaire during every clinical visit. Questionnaire includes 15 items with a numeric rating scale from 0 to 10 for each item and allows the assessment of hearing with and without hearing aids. Higher scores mean worse outcome.
Time frame: Change measures: 0 months, 2 months, 4 months, 6 months.
Performance-based Outcome: Finnish matrix Sentence Test (FMST)
Participants will conduct Finnish Matrix Sentence Test (FMST) during every clinical visit. This test measures participants' speech perception in noise.
Time frame: Change measures: 0 months, 2 months, 4 months, 6 months.
Performance-based Outcome: Digit Triple Test (DTT)
Participants will conduct Digit Triple Test (DTT) during every clinical visit. This test measures participants' speech perception in noise.
Time frame: Change measures: 0 months, 2 months, 4 months, 6 months.
Objective differences of the fitting parameters
Difference in desibel levels between initial fit and REM
Time frame: Change measures: 0 months and 2 months
Fitting preference
Participants' preferences are measured by likert scale (1-10).
Time frame: 12 months after the beginning of clinical visits
Hearing aid usage
Participants' self-reported hearing aid usage and log-data report are recorded.
Time frame: 12 months after the beginning of clinical visits
Cost effectiveness
Additional time consumption for REM and number of additional contacts to the clinic are recorded.
Time frame: Between 0-12 months.
Plan to share: No
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kuopio University Hospital