Hearing LossNCT04926636
A System and Process to Improve the Satisfaction With Hearing Health Products
A study testing Health and Wellness Coaching in people with Hearing Loss, run by University of Minnesota at 1 site in United States.
Trial summary
Innovative Design Labs Inc. (IDL) and its collaborators, proposes to create a cloud-based system which integrates advances and techniques from Health and Wellness Coaching (HWC) into the Hearing Aid (HA) fitting and trial process. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Health and Wellness Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- Significantly reduced cognitive ability (assessed using the Montreal Cognitive Assessment MoCA)
- Lack of proficiency communicating in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Innovative Design Labs Inc. (IDL) and its collaborators, proposes to create a cloud-based system which integrates advances and techniques from Health and Wellness Coaching (HWC) into the Hearing Aid (HA) fitting and trial process.
Read the detailed description
As of 2015, 28.8 million U.S. adults could benefit from using hearing aids and the prevalence of hearing loss in the United States is predicted to rise significantly due to an aging population and the growing use of personal listening devices. However, only 28.5% of individuals who could benefit from a HA actually wears one. The non-use of hearing aids by people with hearing loss has many far-reaching implications for their physical health, mental health, and their social life. As the market moves towards a, direct-to-consumer distribution model following the 2017 FDA directive, more patients will be receiving therapy for hearing loss. While in traditional practice, an audiologist assists the patient with support adjusting to their new therapy, there is no person fulfilling that role in the direct-to-consumer model. Hypothesis: The investigators hypothesize that the integration of Health and Wellness Coaching, aided by cloud-based tools, into this process will increase patients' satisfaction and usage of hearing health products. Specific Aims: 1) Create patient/coach interaction protocol and training; 2) Develop a cloud-based Health Coaching Interface; 3) Evaluate system effectiveness through a clinical trial.
- Conditions
- Hearing Loss
- Being tested
- Health and Wellness Coaching
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health and Wellness CoachingBehavioural
An enhanced mobile application that allows for participation in health coaching features. Participants will be assigned to a health coach and will have coaching sessions scheduled.
| Study group | Role | What they receive |
|---|---|---|
| Standard Mobile App | No intervention | This group will be supplied with Novidan DTC hearing aids and documentation following standard of care as a control. They will be provided with the mobile application allowing for the monitoring of data for study analysis and personal control of their hearing aids, but not Health and Wellness Coaching features. |
| Enhanced Mobile App with Health Coaching | Experimental | This group will also be supplied with the Novidan DTC hearings aids and documentation, same as the control group, but will be supplied the enhanced mobile application that allows for participation in health coaching features. They will be assigned to a health coach and will have coaching sessions scheduled. Receives: Behavioral: Health and Wellness Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
COSI Goal Achievement
The Client Oriented Scale of Improvement (COSI) questionnaire tracks the goals and needs of the patient through their hearing aid fitting process. Items allow the patient to qualify their degree of change for each of their needs/goals as 1) Much Worse 2) Worse 3) No Difference 4) Better 5) Much Better. Total scores are an average of item scores and range from 1 to 5 with higher scores indicating more improvement.
Measured: 3 months
Hours of Hearing Aid Use
Hearing aid usage information for both groups will be automatically logged on non-volatile memory inside of the hearing aid. It will record the amount of time in hours the user spent wearing their hearing aids. It is accessed and downloaded through the provided companion smartphone application.
Measured: 3 months
Adherence to Program
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start31 Dec 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926636
- Sponsor's protocol ID
- STUDY00010555
- Status last verified
- Feb 2026
- First submitted
- 8 Jun 2021
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A System and Process to Improve the Satisfaction With Hearing Health Products
- ClinicalTrials.gov ID
- NCT04926636
- Acronym / sponsor ID
- STUDY00010555
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 31 Dec 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Posted 20 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Innovative Design Labs Inc. (IDL) and its collaborators, proposes to create a cloud-based system which integrates advances and techniques from Health and Wellness Coaching (HWC) into the Hearing Aid (HA) fitting and trial process.
Detailed description
As of 2015, 28.8 million U.S. adults could benefit from using hearing aids and the prevalence of hearing loss in the United States is predicted to rise significantly due to an aging population and the growing use of personal listening devices. However, only 28.5% of individuals who could benefit from a HA actually wears one. The non-use of hearing aids by people with hearing loss has many far-reaching implications for their physical health, mental health, and their social life. As the market moves towards a, direct-to-consumer distribution model following the 2017 FDA directive, more patients will be receiving therapy for hearing loss. While in traditional practice, an audiologist assists the patient with support adjusting to their new therapy, there is no person fulfilling that role in the direct-to-consumer model. Hypothesis: The investigators hypothesize that the integration of Health and Wellness Coaching, aided by cloud-based tools, into this process will increase patients' satisfaction and usage of hearing health products. Specific Aims: 1) Create patient/coach interaction protocol and training; 2) Develop a cloud-based Health Coaching Interface; 3) Evaluate system effectiveness through a clinical trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Mobile App | No intervention | –This group will be supplied with Novidan DTC hearing aids and documentation following standard of care as a control. They will be provided with the mobile application allowing for the monitoring of data for study analysis and personal control of their hearing aids, but not Health and Wellness Coaching features. |
| Enhanced Mobile App with Health Coaching | Experimental | Behavioral: Health and Wellness CoachingThis group will also be supplied with the Novidan DTC hearings aids and documentation, same as the control group, but will be supplied the enhanced mobile application that allows for participation in health coaching features. They will be assigned to a health coach and will have coaching sessions scheduled. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (2 listed)
- Significantly reduced cognitive ability (assessed using the Montreal Cognitive Assessment MoCA)
- Lack of proficiency communicating in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health and Wellness CoachingAn enhanced mobile application that allows for participation in health coaching features. Participants will be assigned to a health coach and will have coaching sessions scheduled. | Behavioural | Enhanced Mobile App with Health Coaching |
Primary outcome
COSI Goal Achievement
Time frame: 3 months
The Client Oriented Scale of Improvement (COSI) questionnaire tracks the goals and needs of the patient through their hearing aid fitting process. Items allow the patient to qualify their degree of change for each of their needs/goals as 1) Much Worse 2) Worse 3) No Difference 4) Better 5) Much Better. Total scores are an average of item scores and range from 1 to 5 with higher scores indicating more improvement.
Hours of Hearing Aid Use
Time frame: 3 months
Hearing aid usage information for both groups will be automatically logged on non-volatile memory inside of the hearing aid. It will record the amount of time in hours the user spent wearing their hearing aids. It is accessed and downloaded through the provided companion smartphone application.
Adherence to Program
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health and Wellness Coaching in people with Hearing Loss, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COSI Goal Achievement (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.