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NCT Number: NCT03579563

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

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.

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Key information

Conditions

Presbycusis Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa, Iowa City, Iowa, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AUD fitting

Other

Prescription hearing aids will be fitted by audiologists using established procedures.

OTC+ fitting

Other

Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids.

OTC fitting

Other

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.

High-end HA

Device

High-end hearing aids will be used.

Low-end HA

Device

Low-end hearing aids will be used.

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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. 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).

Sponsors and collaborators

Lead sponsor

Yu-Hsiang Wu

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2018
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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