Impact of Hearing Aid Technology on Self-reported Outcomes

Sponsor
University of Southern Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT04539847
Collaborator
Odense University Hospital (Other)
208
2
17

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High-end hearing aid
  • Device: Basic hearing aid
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
208 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
two-arm parallel assignmenttwo-arm parallel assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Impact of Hearing Aid Technology on Self-reported Outcomes in Patients With Presbycusis - a Randomized Controlled Trial
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: High-end hearing aid

Patients will be fitted with premium level hearing aid technology

Device: High-end hearing aid
hearing aid with premium level of technology
Other Names:
  • Oticon
  • Resound
  • Widex
  • Experimental: Basic hearing aid

    Patients will be fitted with basic level hearing aid technology

    Device: Basic hearing aid
    hearing aid with basic level of technology
    Other Names:
  • Oticon
  • Resound
  • Widex
  • Outcome Measures

    Primary Outcome Measures

    1. International Outcome Inventory for Hearing Aids [two months]

      Hearing aid benefit questionnaire that consists of seven questions targeting different outcome domains. Each question is scored on a scale from 1 to 5 where a higher score indicates a better outcome.

    2. Speech, Spatial, and Quality of hearing scale (the short form) [two months]

      Hearing aid benefit questionnaire that consists of 12 questions targeting the hearing ability in different situations. Each question is ranked on a scale from 0 to 10 where a lower score indicates a greater disability.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients diagnosed with presbycusis
    Exclusion Criteria:
    • Not being able to fill out questionnaires

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Southern Denmark
    • Odense University Hospital

    Investigators

    • Principal Investigator: Jesper H Schmidt, PhD, MD, Odense University Hospital, Region of Southern Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern Denmark
    ClinicalTrials.gov Identifier:
    NCT04539847
    Other Study ID Numbers:
    • shoumoeller
    First Posted:
    Sep 7, 2020
    Last Update Posted:
    Oct 20, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Southern Denmark
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 20, 2020