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Impact of Hearing Aid Technology on Self-reported Outcomes

University of Southern Denmark (SDU) logo

University of Southern Denmark (SDU)

Status

Completed

Conditions

Presbycusis, Bilateral

Treatments

Device: High-end hearing aid
Device: Basic hearing aid

Study type

Interventional

Funder types

Other

Identifiers

NCT04539847
shoumoeller

Details and patient eligibility

About

The study aims to investigate if the level of hearing aid (HA) technology has an impact on self-reported outcomes in patients with presbycusis in terms of overall IOI-HA scores, Factor 1, Factor 2 scores, SSQ scores, and the SSQ domains. The study explores if presbycusis patients report better outcomes with premium level HA technology compared to basic level HA technology. Further, the study investigates if premium level HAs provide more high-frequency gain than basic HAs using Real Ear Measurements.

Full description

In hearing rehabilitation clinics today, the choice of hearing aid (HA) technology level is primarily based on the individual hearing care providers´ preferences. There is a lack of knowledge in which level of HA technology should be chosen for patients with presbycusis and if these patients will report higher benefit from more technologically advanced hearing aids. Therefore, this study aims to investigate if level of hearing aid technology has an impact on self-reported outcomes measures as the IOI-HA, SSQ, and 15-D questionnaire in patients with presbycusis.

The study was designed as a two-arm parallel randomized controlled trial. A subgroup of patients diagnosed with presbycusis and participating in the Danish National Better hEAring Rehabilitation (BEAR) project was invited to participate in the study.

Data was collected from the Department of Audiology at Odense University Hospital (OUH), Region of Southern Denmark.

All patients underwent a hearing examination which consisted of a pure-tone audiometry, bone-conduction thresholds at 250 Hz to 4 kHz, and a measure of word recognition scores (WRS) and speech reception thresholds (SRT) detecting the threshold at the 50% correct response level.

The questionnaires were sent to all patients two weeks prior to the first visit in clinic and included; a non-standardized health-related questionnaire containing questions on demographic details such as sex, age, HA experience, motivation and the SSQ questionnaire. The IOI-HA questionnaire was sent if patients were experienced HA users at the time of inclusion. All questionnaires were compiled and managed using Research Electronic Data Capture (REDCap) tools developed by Vanderbilt University, Nashville, Tennessee, United States (Harris et al. 2009, 2019) and is hosted by Odense Patient Explorative Network (OPEN) in the Region of Southern Denmark. Patients received the questionnaires through an online link generated by REDCap, but a paper-and-pencil version was also available if necessary when they entered the clinic.

Patients were randomized into two groups based on age, sex and WRS, and fitted with either a high-end or a basic level hearing aid.

Approximately two months after hearing aid fitting, a follow-up visit was scheduled where a Real Ear Measurement (REM) was carried out. The IOI-HA and SSQ questionnaires were re-sent to all patients two weeks prior the follow-up visit.

Enrollment

208 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients diagnosed with presbycusis

Exclusion criteria

  • Not being able to fill out questionnaires

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

208 participants in 2 patient groups

High-end hearing aid
Experimental group
Description:
Patients will be fitted with premium level hearing aid technology
Treatment:
Device: High-end hearing aid
Basic hearing aid
Experimental group
Description:
Patients will be fitted with basic level hearing aid technology
Treatment:
Device: Basic hearing aid

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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