N/A
N=34
Longitudinal Outcomes of Hearing Aids
Presbycusis
Bottom Line
View on ClinicalTrials.gov: NCT04030299 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP) — 3.68; 3.55; 3.63 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Over-the-counter fitting (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Yu-Hsiang Wu
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP) |
3.68; 3.55; 3.63 | — |
| SECONDARY Hearing Aid Performance/Benefit as Measured Using the Profile of Hearing Aid Performance (PHAP) |
30.5; 30.4; 29.5 | — |
| SECONDARY Hearing Handicap as Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA) |
20.2; 13; 17.7 | — |
| SECONDARY Hearing Aid Satisfaction as Measured by the Hearing Aid Satisfaction Survey (HASS) |
3.6; 3.5; 3.5 | — |
| SECONDARY Willingness-to-pay |
967.7; 1104.7 | — |
| SECONDARY Quality of Life as Measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) |
7.5; 6.7; 7.5 | — |
| SECONDARY Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL) |
4.6; 4.4; 4.6 | — |
| SECONDARY Speech Recognition Performance as Measured by the Connected Speech Test (CST) |
64.9; 79.6; 76.8 | — |
Summary
Age-related hearing loss is a substantial national problem due to its high prevalence and significant psychosocial consequences. Although hearing aids (HAs) are the primary intervention for the management of age-related hearing loss, only 15-30% of those who could benefit from HAs actually seek them out. HA adoption rates are even worse for people with lower income and for racial and ethnic minorities. One of the most commonly reported reasons for people not seeking HA intervention is the high cost of HAs and the associated audiological fitting services. Because HAs fitted using the audiologist-based service-delivery model are unaffordable, more and more Americans (1.5 million in 2010) purchase amplification devices via over-the-counter (OTC) service-delivery models to compensate for their impaired hearing.
Although OTC amplification devices are gaining popularity and are regarded as an important option for promoting accessible and affordable hearing healthcare, it is unclear if they are viable solutions for age-related hearing loss as OTC models exclude professional services. Further, although there is some evidence supporting the effectiveness of OTC HAs, all previous studies measured short-term outcomes (e.g., 6 weeks). It is unknown what the long-term outcomes of OTC HAs would look like. The outcomes could improve across time because users may eventually figure out how to use HAs. On the other hand, the outcomes of OTC HAs could become poorer across time because, unlike traditional HA fitting, users do not have professionals to support them. Therefore, the overall goal of this project is to examine the longitudinal changes in OTC HA outcomes over 3 months.
Eligibility Criteria
Inclusion Criteria
- adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss
Exclusion Criteria
- Non-native speaker of English
Data sourced from ClinicalTrials.gov (NCT04030299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.