Impact of Hearing Aid Technology on Self-reported Outcomes
1 other identifier
interventional
208
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 31, 2020
CompletedFirst Posted
Study publicly available on registry
September 7, 2020
CompletedOctober 20, 2020
June 1, 2020
1.4 years
August 31, 2020
October 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
International Outcome Inventory for Hearing Aids
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.
two months
Speech, Spatial, and Quality of hearing scale (the short form)
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.
two months
Study Arms (2)
High-end hearing aid
EXPERIMENTALPatients will be fitted with premium level hearing aid technology
Basic hearing aid
EXPERIMENTALPatients will be fitted with basic level hearing aid technology
Interventions
hearing aid with premium level of technology
hearing aid with basic level of technology
Eligibility Criteria
You may qualify if:
- Patients diagnosed with presbycusis
You may not qualify if:
- Not being able to fill out questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Denmarklead
- Odense University Hospitalcollaborator
Related Publications (1)
Houmoller SS, Wolff A, Tsai LT, Narayanan SK, Hougaard DD, Gaihede ML, Neher T, Godballe C, Schmidt JH. Impact of hearing aid technology level at first-fit on self-reported outcomes in patients with presbycusis: a randomized controlled trial. Front Aging. 2023 Jun 1;4:1158272. doi: 10.3389/fragi.2023.1158272. eCollection 2023.
PMID: 37342862DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesper H Schmidt, PhD, MD
Odense University Hospital, Region of Southern Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2020
First Posted
September 7, 2020
Study Start
December 1, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
October 20, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share
All personal data will become anonymized and handled with full confidentiality in compliance with the Personal Data Processing Act and GDPR. The procedure of personal data processing will be reported to the Danish Data Protection Agency (Datatilsynet) in Odense University Hospital, Region of Southern Denmark.