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

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

Interventions

OTHER

Hearing Aid Manufacturer's Software

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.

OTHER

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.

Sponsors & Collaborators

• Turku University Hospital

  collaborator OTHER_GOV

• Kuopio University Hospital

  lead OTHER

Principal Investigators

• Aarno Dietz, Prof. · ENT specialist

• Matti Iso-Mustajärvi, Ass. prof. · ENT specialist

• Laura Ihalainen, MD · ENT specialist

• Tytti Willberg, PhD · ENT specialist

• Pia Linder, PhD · Medical engineer

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-07

Primary Completion

2025-09-12

Completion

2025-09-12

Countries

• Finland

Study Locations