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

October 8, 2024 updated by: Yu-Hsiang Wu

Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes: A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Age-related hearing loss presents a significant national challenge due to its high prevalence and significant quality-of-life consequences. Although hearing aids (HAs) are the primary choice for managing age-related hearing loss, their adoption rate remains low. One commonly reported reason for not adopting HAs is the financial and physical barriers associated with traditional hearing healthcare, which involves multiple visits to licensed professionals (such as audiologists) for diagnosis and a lengthy process of fitting and fine-tuning prescription HAs. This traditional service-delivery model is referred to as the AUD service model.

Additionally, a variety of technologies and features have been implemented in HAs, including multi-channel wide dynamic range compression, directional microphones, noise reduction algorithms, and wireless functionality. These technologies have evolved from basic algorithms into more sophisticated and complex designs. The high-end technologies and features often make HAs more expensive, further exacerbating the accessibility and affordability issues of traditional hearing healthcare.

In recent years, over-the-counter (OTC) HAs have emerged as an alternative to address some of the affordability and accessibility issues of the AUD service. This direct-to-consumer model enables users to self-determine hearing loss, self-fit OTC HAs, and self-manage the device without the need for professional support. This direct-to-consumer model is referred to as the OTC service model. Additionally, it has been advocated that a hybrid service model, where professionals fit OTC HAs (referred to as the OTC+ service model), could offer affordable and quality amplification interventions.

Previous clinical trials have shown that the OTC service model yields outcomes comparable to the AUD service model. Furthermore, prior research has found no statistically significant or clinically important differences in patient outcomes between high-end and low-end HAs. However, no prior research has systematically examined the effectiveness of HA fitting service models and HA technology levels in the same study. Additionally, no prior research has investigated the patient outcomes of the OTC+ service model.

The objective of the study is to determine the effect of HA fitting services (AUD, OTC+, and OTC) and technology levels (high-end and low-end) on patient outcomes. This is a two-site randomized controlled trial. Participants will be randomly assigned to one of six parallel arms, which are factorial combinations of three service models (AUD, OTC+, and OTC) and two HA technology levels (high-end and low-end). Baseline measures will be administered before HA fitting and patient outcomes will be assessed six to seven weeks post-HA fitting.

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AUD/High-end
In this group, the audiologist-based fitting will be used to provide high-end hearing aids.
Other: AUD fitting
Prescription hearing aids will be fitted by audiologists using established procedures.
Device: High-end HA
High-end hearing aids will be used.
Experimental: OTC+/High-end
In this group, audiologists will provide brief services to fit high-end OTC hearing aids
Device: High-end HA
High-end hearing aids will be used.
Other: OTC+ fitting
Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids.
Experimental: OTC/High-end
In this group, high-end OTC hearing aids will be provided to subjects.
Device: High-end HA
High-end hearing aids will be used.
Other: OTC fitting
In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Active Comparator: AUD/Low-end
In this group, the audiologist-based fitting will be used to provide low-end hearing aids.
Other: AUD fitting
Prescription hearing aids will be fitted by audiologists using established procedures.
Device: Low-end HA
Low-end hearing aids will be used.
Experimental: OTC+/Low-end
In this group, audiologists will provide brief services to fit low-end OTC hearing aids.
Other: OTC+ fitting
Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids.
Device: Low-end HA
Low-end hearing aids will be used.
Experimental: OTC/Low-end
In this group, low-end OTC hearing aids will be provided to subjects.
Other: OTC fitting
In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Device: Low-end HA
Low-end hearing aids will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Aid Use Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Use)
Time Frame: 7-weeks post-intervention
The GHABP is a questionnaire that measures hearing aid (HA) users' listening experience in four situations: TV listening, small conversation in quiet, conversation in noise, and group conversation. The GHABP will be administered using smartphone-based Ecological Momentary Assessment (EMA) to collect in-situ reports. Scores from the items that evaluate patient's HA use are averaged across the four situations to form the EMA-GHABP-Use score. The score ranges from 1 (not use HA at all) to 5 (use HA all the time).
7-weeks post-intervention
Hearing Aid Benefit Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Global)
Time Frame: 7-weeks post-intervention
The GHABP is a questionnaire that measures hearing aid (HA) users' listening experience in four situations: TV listening, small conversation in quiet, conversation in noise, and group conversation. The GHABP will be administered using smartphone-based Ecological Momentary Assessment (EMA) to collect in-situ reports. Scores from the items that evaluate a patient's hearing disability, hearing handicap, HA benefit, and HA satisfaction are averaged across the four situations to form the EMA-GHABP-Global score. The score ranges from 1 (poorer outcome) to 5 (better outcome).
7-weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Hearing Aid Performance Measured Using the Profile of Hearing Aid Performance (PHAP)
Time Frame: pre-intervention and 7 weeks post-intervention
The PHAP is a questionnaire designed to measures the performance of hearing aids in speech communication. The score ranges from 1 (good performance) to 99 (poor performance) (i.e., lower scores mean better performance). Participants will complete this questionnaire pre-intervention and at 7 weeks post-intervention. The change in scores between pre- and post-intervention will be used for analysis, with score changes ranging from -98 (indicating a benefit from hearing aids) to +98 (indicating a detrimental effect of hearing aids).
pre-intervention and 7 weeks post-intervention
Change of Speech Recognition Performance as Measured by the Connected Speech Test (CST)
Time Frame: pre-intervention and 6 weeks post-intervention
The CST is a speech recognition test designed to simulate daily speech communication. The score ranges from 0 (understand no speech) to 100 (understand all speech). Participants will complete this questionnaire pre-intervention and at 6 weeks post-intervention. The change in scores between pre- and post-intervention will be used for analysis, with score changes ranging from -100 (indicating a detrimental effect of hearing aids) to +100 (indicating a benefit from hearing aids).
pre-intervention and 6 weeks post-intervention
Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)
Time Frame: pre-intervention and 7 weeks post-intervention
The HHIE and HHIA are questionnaires designed to measure subject's perceived hearing handicap. For subjects order and younger 65 years old, the HHIE and HHIA will be used, respectively. The score ranges from 0 (no handicap) to 100 (more handicap) (i.e., lower scores mean less handicap). Participants will complete this questionnaire pre-intervention and at 7 weeks post-intervention. The change in scores between pre- and post-intervention will be used for analysis, with score changes ranging from -100 (indicating a benefit from hearing aids) to +100 (indicating a detrimental effect of hearing aids).
pre-intervention and 7 weeks post-intervention
Hearing Aid Use Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Use)
Time Frame: 6-week post-intervention
The GHABP is a questionnaire that measures hearing aid (HA) users' listening experience in four situations: TV listening, small conversation in quiet, conversation in noise, and group conversation. The GHABP will be administered using retrospective questionnaires. Scores from the items that evaluate patient's HA use are averaged across the four situations to form the Retro-GHABP-Use score. The score ranges from 1 (not use HA at all) to 5 (use HA all the time).
6-week post-intervention
Hearing Aid Benefit Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Global)
Time Frame: 6 weeks post-intervention
The GHABP is a questionnaire that measures hearing aid (HA) users' listening experience in four situations: TV listening, small conversation in quiet, conversation in noise, and group conversation. The GHABP will be administered using retrospective questionnaires. Scores from the items that evaluate a patient's hearing disability, hearing handicap, HA benefit, and HA satisfaction are averaged across the four situations to form the Retro-GHABP-Global score. The score ranges from 1 (poorer outcome) to 5 (better outcome).
6 weeks post-intervention
Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL)
Time Frame: 7-week post-intervention
The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction).
7-week post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yu-Hsiang Wu

Collaborators

Vanderbilt University Medical Center
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Yu-Hsiang Wu, PhD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2019

Primary Completion (Actual)

December 22, 2023

Study Completion (Actual)

December 22, 2023

Study Registration Dates

First Submitted

June 25, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201804771
  • 1R01DC015997-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The proposed research will include data from a total of 240 participants with hearing loss recruited State of Iowa, State of Tennessee and surrounding areas. The final dataset will include laboratory data (e.g., speech recognition score) and self-reported demographic and behavioral data (e.g., questionnaire). Contact the principle investigator for data access.

IPD Sharing Time Frame

The date will be available starting 6 months after publication of the main findings of the trial.

IPD Sharing Access Criteria

Even though the final dataset will be stripped of identifiers prior to release for sharing, there remains the possibility of deductive disclosure of subjects with the survey data being collected. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate technologies; and (3) a commitment to destroying or returning the data after analyses are completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Presbycusis

Clinical Trials on AUD fitting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe