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

NCT05621798 | Completed

• 1 other identifier: 5551888
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sensorineural Hearing Loss, Bilateral

Keywords

REM; Real Ear Measurements; Sensorineural Hearing Loss; Hearing Aid Fitting; Speech Intelligibility Tests in Noise; HERE; SSQ-49

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Change measures: 0 months, 2 months, 4 months, 6 months.

Secondary Outcomes (4)

• Objective differences of the fitting parameters

  Change measures: 0 months and 2 months

• Fitting preference

  12 months after the beginning of clinical visits

• Hearing aid usage

  12 months after the beginning of clinical visits

• Cost effectiveness

  Between 0-12 months.

Study Arms (2)

Hearing Aid Manufacturer's Software Group

ACTIVE COMPARATOR

Participants' hearing aids are fitted by using manufacturer's software.

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.

Other: Hearing Aid Manufacturer's Software; Other: REM (Real Ear Measurements)

Interventions

Hearing Aid Manufacturer's Software OTHER

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.

Hearing Aid Manufacturer's Software Group; REM Group

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.

Hearing Aid Manufacturer's Software Group; REM Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• confirmed cases of cognitive decline or dementia
• unilateral or conductive hearing impairment

Sponsors & Collaborators

• Kuopio University Hospital: lead
• Turku University Hospital: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, 70210, Finland

Location

Related Publications (12)

• 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.

  PMID: 23169194 BACKGROUND

• Almufarrij 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.

  PMID: 33899603 BACKGROUND

• Almufarrij 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.

  PMID: 32690533 BACKGROUND

• Denys 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.

  PMID: 30513024 BACKGROUND

• Scollie 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.

  PMID: 20109089 BACKGROUND

• Hawkings DP, Cook JA. Hearing aid software predictive gain values: How accurate are they? The Hearing Journal. 2003; 56(7): 26-34.

  BACKGROUND

• 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.

  PMID: 16028792 BACKGROUND

• Aazh 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.

  PMID: 22023487 BACKGROUND

• Aazh 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.

  PMID: 18326152 BACKGROUND

• Mueller HG, Picou EM. Survey examines popularity of real-ear probe-microphone measures. Hearing Journal. 2010; 63(5): 27-32.

  BACKGROUND

• 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.

  PMID: 30222541 BACKGROUND

• Walravens 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.

  PMID: 32602407 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Sleep, REM

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sleep Stages; Sleep; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Aarno Dietz, Prof.

  ENT specialist

  STUDY CHAIR

• Matti Iso-Mustajärvi, Ass. prof.

  ENT specialist

  STUDY DIRECTOR

• Laura Ihalainen, MD

  ENT specialist

  PRINCIPAL INVESTIGATOR

• Tytti Willberg, PhD

  ENT specialist

  STUDY DIRECTOR

• Pia Linder, PhD

  Medical engineer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients are having their hearing aids fitted by manufacturer's initial fit method or by REM. In both fittings participants will be hearing sounds at different intensities and frequencies but they are unaware of the exact fitting method used. The "first fit" and REM measurement sounds and procedures are different, but for first-time users unknown. Both procedures are conducted by audiologist but only the other of the fitting results is being used for the hearing aid adjusting. During the next fitting appointment the participant is also seen and the hearing aid is re-fitted by another audiologist than the first time.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: November 18, 2022
• Study Start: September 7, 2022
• Primary Completion: September 12, 2025
• Study Completion: September 12, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)