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N/A N=290 Randomized Double-blind Health Services Research

Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes

Presbycusis

Enrolled (actual)
290
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Hearing Aid Use Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Use) — 4.4; 4.1; 3.8; 4.5 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
AUD fitting (Other); OTC+ fitting (Other); OTC fitting (Other); High-end HA (Device); Low-end HA (Device)
Age
Adult, Older Adult · 55+ yrs
Sex
All
Sponsor
Yu-Hsiang Wu
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Hearing Aid Use Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Use)
4.4; 4.1; 3.8; 4.5; 3.8; 4.3
PRIMARY
Hearing Aid Benefit Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Global)
4.1; 3.9; 3.9; 4.1; 3.8; 3.9
SECONDARY
Change of Hearing Aid Performance Measured Using the Profile of Hearing Aid Performance (PHAP)
-17.7; -14.2; -15.2; -16.1; -13.4; -13.6
SECONDARY
Change of Speech Recognition Performance as Measured by the Connected Speech Test (CST)
10.5; 5; 6.7; 4.6; 2.2; 6.4
SECONDARY
Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)
-23.3; -13.7; -15; -17.7; -14; -13
SECONDARY
Hearing Aid Use Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Use)
4.3; 3.9; 3.5; 4.2; 3.4; 4
SECONDARY
Hearing Aid Benefit Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Global)
3.9; 3.7; 3.7; 3.9; 3.5; 3.7
SECONDARY
Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL)
5.4; 4.9; 4.9; 5.4; 4.8; 4.7

Summary

Age-related hearing loss is a big problem in the United States because many people have it and it affects their quality of life. Hearing aids can help, but not many people use them. One reason is that getting hearing aids can be expensive and difficult. People usually have to visit doctors, like audiologists, many times to get their hearing tested and have the hearing aids fitted and adjusted. This process is called the AUD service model in this study. Hearing aids come with different technologies and features, like directional microphones and noise reduction algorithms. These features can make hearing aids work better but also make them more expensive, which can be another barrier for people who need them. Recently, over-the-counter (OTC) hearing aids have become available. These hearing aids are cheaper and easier to get because people can buy them directly and fit them on their own without seeing a doctor. This is called the OTC service model in this study. Another service model that could be great is a "hybrid" service model, where professionals help fit the OTC hearing aids. This hybrid model can make hearing aids both affordable and high quality. Studies have shown that the OTC service model works as well as the AUD service model. Additionally, other research has found no big differences in how well high-end and low-end hearing aids work for patients. However, no one has studied the different service models and technology levels together in one study, and no one has looked at how well the hybrid service model (called the OTC+ service model in this study) works. The goal of this study is to find out how the different ways of fitting hearing aids (AUD, OTC+, and OTC) and the different technology levels (high-end and low-end) affect patient outcomes. The study will take place at two sites and will be a randomized controlled trial. Participants will be randomly assigned to one of six groups, which are combinations of the three service models and two technology levels. Measurements will be taken before the hearing aids are fitted and again six to seven weeks after fitting to see how well the hearing aids are working for the patients.

Eligibility Criteria

Inclusion Criteria

  • adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss
  • Puretone average across 500, 1000, 2000, and 4000 Hz between 25 and 55 dB HL
  • Thresholds from 500-4000 Hz no poorer than 65 dB HL, with up to 2 thresholds outside this criterion by < 10 dB still being eligible.
  • no previous hearing aid experience

Exclusion Criteria

  • Non-native speaker of English
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03579563). 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.

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