Sensorineural Hearing Loss, BilateralBREMNCT05621798
Quantifying the Benefits and Cost-effectiveness of Real-Ear Measurements (REM) for Hearing Aid Fitting
A study testing Hearing Aid Manufacturer's Software and REM (Real Ear Measurements) in people with Sensorineural Hearing Loss, Bilateral, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensorineural Hearing Loss, Bilateral
- What is being tested?
- Hearing Aid Manufacturer's Software and REM (Real Ear Measurements)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFinland
- Study dates
- 7 Sep 2022to 12 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- confirmed cases of cognitive decline or dementia
- unilateral or conductive hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Being tested
- Hearing Aid Manufacturer's Software, REM (Real Ear Measurements)
- Keywords
- REM, Real Ear Measurements, Sensorineural Hearing Loss, Hearing Aid Fitting, Speech Intelligibility Tests in Noise, HERE, SSQ-49
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Aid Manufacturer's SoftwareOther
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.
REM (Real Ear Measurements)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid Manufacturer's Software Group | Active comparator | Participants' hearing aids are fitted by using manufacturer's software. Receives: Other: Hearing Aid Manufacturer's Software; Other: REM (Real Ear Measurements) |
| REM Group | Active comparator | Participants' hearing aids are fitted by REM (Real Ear Measurements) method. Receives: Other: Hearing Aid Manufacturer's Software; Other: REM (Real Ear Measurements) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change measures: 0 months, 2 months, 4 months, 6 months.
Secondary outcomes (4)
Objective differences of the fitting parameters
Difference in desibel levels between initial fit and REM
Measured: Change measures: 0 months and 2 months
Fitting preference
Participants' preferences are measured by likert scale (1-10).
Measured: 12 months after the beginning of clinical visits
Hearing aid usage
Participants' self-reported hearing aid usage and log-data report are recorded.
Measured: 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.
Measured: Between 0-12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start7 Sep 2022
- Primary completion12 Sep 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Sensorineural Hearing Loss, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- On the first fit visit the participants will be fitted either with the manufacturers "first-fit" or "initial fit" program or using the REM measurements. We will randomize all patients into two groups; Half of the participants will be fitted with the Phonak "first fit" fitting rule and the other half using the Phonak TargetMatch that utilizes REM fitting. After around 2-3 months, depending on the clinic schedule, the participants will be crossed-over to the other method, so that the group that first got the manufacturers fit will now receive the fit based on REM and vice versa. Third visit will take place 2-3 months after the second visit and the participants will get to choose which fit they will prefer for their hearing aids. Fourth visit takes place around 6 months after the third visit when the participants have been wearing their hearing aids for a year.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital
- Responsible party
- Sponsor
- Investigators
- Aarno Dietz, Prof., Study chair, ENT specialistMatti Iso-Mustajärvi, Ass. prof., Study director, ENT specialistLaura Ihalainen, MD, Principal investigator, ENT specialistTytti Willberg, PhD, Study director, ENT specialistPia Linder, PhD, Study director, Medical engineer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621798
- Sponsor's protocol ID
- 5551888
- Acronym
- BREM
- Status last verified
- Feb 2026
- First submitted
- 11 Aug 2022
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abrams HB, Chisolm TH, McManus M, McArdle R. Initial-fit approach versus verified prescription: comparing self-perceived hearing aid benefit. J Am Acad Audiol. 2012 Nov-Dec;23(10):768-78. doi: 10.3766/jaaa.23.10.3.
PubMed 23169194Almufarrij I, Dillon H, Munro KJ. Does Probe-Tube Verification of Real-Ear Hearing Aid Amplification Characteristics Improve Outcomes in Adults? A Systematic Review and Meta-Analysis. Trends Hear. 2021 Jan-Dec;25:2331216521999563. doi: 10.1177/2331216521999563.
PubMed 33899603Almufarrij I, Munro KJ, Dillon H. Does probe-tube verification of real-ear hearing aid amplification characteristics improve outcomes in adult hearing aid users? A protocol for a systematic review. BMJ Open. 2020 Jul 19;10(7):e038113. doi: 10.1136/bmjopen-2020-038113.
PubMed 32690533Denys S, Latzel M, Francart T, Wouters J. A preliminary investigation into hearing aid fitting based on automated real-ear measurements integrated in the fitting software: test-retest reliability, matching accuracy and perceptual outcomes. Int J Audiol. 2019 Mar;58(3):132-140. doi: 10.1080/14992027.2018.1543958. Epub 2018 Dec 4.
PubMed 30513024Scollie S, Ching TY, Seewald R, Dillon H, Britton L, Steinberg J, Corcoran J. Evaluation of the NAL-NL1 and DSL v4.1 prescriptions for children: Preference in real world use. Int J Audiol. 2010 Jan;49 Suppl 1:S49-63. doi: 10.3109/14992020903148038.
PubMed 20109089Hawkings DP, Cook JA. Hearing aid software predictive gain values: How accurate are they? The Hearing Journal. 2003; 56(7): 26-34.
Aarts NL, Caffee CS. Manufacturer predicted and measured REAR values in adult hearing aid fitting: accuracy and clinical usefulness. Int J Audiol. 2005 May;44(5):293-301. doi: 10.1080/14992020500057830.
PubMed 16028792Aazh H, Moore BC, Prasher D. Real ear measurement methods for open fit hearing aids: modified pressure concurrent equalization (MPCE) versus modified pressure stored equalization (MPSE). Int J Audiol. 2012 Feb;51(2):103-7. doi: 10.3109/14992027.2011.609182. Epub 2011 Oct 24.
PubMed 22023487Aazh H, Moore BC. The value of routine real ear measurement of the gain of digital hearing aids. J Am Acad Audiol. 2007 Sep;18(8):653-64. doi: 10.3766/jaaa.18.8.3.
PubMed 18326152Mueller HG, Picou EM. Survey examines popularity of real-ear probe-microphone measures. Hearing Journal. 2010; 63(5): 27-32.
Valente M, Oeding K, Brockmeyer A, Smith S, Kallogjeri D. Differences in Word and Phoneme Recognition in Quiet, Sentence Recognition in Noise, and Subjective Outcomes between Manufacturer First-Fit and Hearing Aids Programmed to NAL-NL2 Using Real-Ear Measures. J Am Acad Audiol. 2018 Sep;29(8):706-721. doi: 10.3766/jaaa.17005.
PubMed 30222541Walravens E, Keidser G, Hickson L. Consistency of Hearing Aid Setting Preference in Simulated Real-World Environments: Implications for Trainable Hearing Aids. Trends Hear. 2020 Jan-Dec;24:2331216520933392. doi: 10.1177/2331216520933392.
PubMed 32602407
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying the Benefits and Cost-effectiveness of Real-Ear Measurements (REM) for Hearing Aid Fitting
- ClinicalTrials.gov ID
- NCT05621798
- Acronym / sponsor ID
- BREM / 5551888
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Keywords
- REM, Real Ear Measurements, Sensorineural Hearing Loss, Hearing Aid Fitting, Speech Intelligibility Tests in Noise, HERE, SSQ-49
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- On the first fit visit the participants will be fitted either with the manufacturers "first-fit" or "initial fit" program or using the REM measurements. We will randomize all patients into two groups; Half of the participants will be fitted with the Phonak "first fit" fitting rule and the other half using the Phonak TargetMatch that utilizes REM fitting. After around 2-3 months, depending on the clinic schedule, the participants will be crossed-over to the other method, so that the group that first got the manufacturers fit will now receive the fit based on REM and vice versa. Third visit will take place 2-3 months after the second visit and the participants will get to choose which fit they will prefer for their hearing aids. Fourth visit takes place around 6 months after the third visit when the participants have been wearing their hearing aids for a year.
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid Manufacturer's Software Group | Active comparator | Other: Hearing Aid Manufacturer's Software, Other: REM (Real Ear Measurements)Participants' hearing aids are fitted by using manufacturer's software. |
| REM Group | Active comparator | Other: Hearing Aid Manufacturer's Software, Other: REM (Real Ear Measurements)Participants' hearing aids are fitted by REM (Real Ear Measurements) method. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- confirmed cases of cognitive decline or dementia
- unilateral or conductive hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing Aid Manufacturer's SoftwareWhen 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. | Other | Hearing Aid Manufacturer's Software Group, REM Group |
| REM (Real Ear Measurements)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. | Other | Hearing Aid Manufacturer's Software Group, REM Group |
Primary outcome
Patient Related Outcome Measure: Speech, Spatial and Qualities of Hearing Scale (SSQ)
Time frame: Change measures: 0 months, 2 months, 4 months, 6 months.
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.
Patient Related Outcome Measure: Hearing in Real-Life Environments (HERE)
Time frame: Change measures: 0 months, 2 months, 4 months, 6 months.
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.
Performance-based Outcome: Finnish matrix Sentence Test (FMST)
Time frame: Change measures: 0 months, 2 months, 4 months, 6 months.
Participants will conduct Finnish Matrix Sentence Test (FMST) during every clinical visit. This test measures participants' speech perception in noise.
Performance-based Outcome: Digit Triple Test (DTT)
Time frame: Change measures: 0 months, 2 months, 4 months, 6 months.
Participants will conduct Digit Triple Test (DTT) during every clinical visit. This test measures participants' speech perception in noise.
4 secondary outcomes
Objective differences of the fitting parameters
Time frame: Change measures: 0 months and 2 months
Fitting preference
Time frame: 12 months after the beginning of clinical visits
Hearing aid usage
Time frame: 12 months after the beginning of clinical visits
Cost effectiveness
Time frame: Between 0-12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 23169194Abrams HB, Chisolm TH, McManus M, McArdle R. Initial-fit approach versus verified prescription: comparing self-perceived hearing aid benefit. J Am Acad Audiol. 2012 Nov-Dec;23(10):768-78. doi: 10.3766/jaaa.23.10.3.
- Background: PubMed 33899603Almufarrij I, Dillon H, Munro KJ. Does Probe-Tube Verification of Real-Ear Hearing Aid Amplification Characteristics Improve Outcomes in Adults? A Systematic Review and Meta-Analysis. Trends Hear. 2021 Jan-Dec;25:2331216521999563. doi: 10.1177/2331216521999563.
- Background: PubMed 32690533Almufarrij I, Munro KJ, Dillon H. Does probe-tube verification of real-ear hearing aid amplification characteristics improve outcomes in adult hearing aid users? A protocol for a systematic review. BMJ Open. 2020 Jul 19;10(7):e038113. doi: 10.1136/bmjopen-2020-038113.
- Background: PubMed 30513024Denys S, Latzel M, Francart T, Wouters J. A preliminary investigation into hearing aid fitting based on automated real-ear measurements integrated in the fitting software: test-retest reliability, matching accuracy and perceptual outcomes. Int J Audiol. 2019 Mar;58(3):132-140. doi: 10.1080/14992027.2018.1543958. Epub 2018 Dec 4.
- Background: PubMed 20109089Scollie S, Ching TY, Seewald R, Dillon H, Britton L, Steinberg J, Corcoran J. Evaluation of the NAL-NL1 and DSL v4.1 prescriptions for children: Preference in real world use. Int J Audiol. 2010 Jan;49 Suppl 1:S49-63. doi: 10.3109/14992020903148038.
- BackgroundHawkings DP, Cook JA. Hearing aid software predictive gain values: How accurate are they? The Hearing Journal. 2003; 56(7): 26-34.
- Background: PubMed 16028792Aarts NL, Caffee CS. Manufacturer predicted and measured REAR values in adult hearing aid fitting: accuracy and clinical usefulness. Int J Audiol. 2005 May;44(5):293-301. doi: 10.1080/14992020500057830.
- Background: PubMed 22023487Aazh H, Moore BC, Prasher D. Real ear measurement methods for open fit hearing aids: modified pressure concurrent equalization (MPCE) versus modified pressure stored equalization (MPSE). Int J Audiol. 2012 Feb;51(2):103-7. doi: 10.3109/14992027.2011.609182. Epub 2011 Oct 24.
- Background: PubMed 18326152Aazh H, Moore BC. The value of routine real ear measurement of the gain of digital hearing aids. J Am Acad Audiol. 2007 Sep;18(8):653-64. doi: 10.3766/jaaa.18.8.3.
- BackgroundMueller HG, Picou EM. Survey examines popularity of real-ear probe-microphone measures. Hearing Journal. 2010; 63(5): 27-32.
- Background: PubMed 30222541Valente M, Oeding K, Brockmeyer A, Smith S, Kallogjeri D. Differences in Word and Phoneme Recognition in Quiet, Sentence Recognition in Noise, and Subjective Outcomes between Manufacturer First-Fit and Hearing Aids Programmed to NAL-NL2 Using Real-Ear Measures. J Am Acad Audiol. 2018 Sep;29(8):706-721. doi: 10.3766/jaaa.17005.
- Background: PubMed 32602407Walravens E, Keidser G, Hickson L. Consistency of Hearing Aid Setting Preference in Simulated Real-World Environments: Implications for Trainable Hearing Aids. Trends Hear. 2020 Jan-Dec;24:2331216520933392. doi: 10.1177/2331216520933392.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aarno Dietz, Prof. study chair
ENT specialist
Matti Iso-Mustajärvi, Ass. prof. study director
ENT specialist
Laura Ihalainen, MD principal investigator
ENT specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing Aid Manufacturer's Software and REM (Real Ear Measurements) in people with Sensorineural Hearing Loss, Bilateral, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Related Outcome Measure: Speech, Spatial and Qualities of Hearing Scale (SSQ) (time frame: Change measures: 0 months, 2 months, 4 months, 6 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05621798, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.