Hearing LossNCT05165121

Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids

A study testing MDHearing smart hearing aid in people with Hearing Loss, run by MDHearingAid at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hearing Loss
What is being tested?: MDHearing smart hearing aid
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 1 siteUnited States
Study dates: 21 Sep 2020to 24 Sep 2021
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Over 18 years old
At least one air conduction threshold above 15dB HL.
All air conduction thresholds must be under 60dB HL

Who cannot join

Signs of outer or middle ear pathology
Greater than 60db HL hearing loss at any frequency.

Trial locations and contacts

1 site in 1 country.

United States1 site

Central Michigan University
Mount Pleasant, Michigan, 48859

Other trials in United States

About this study

Hearing aids are commonly used to help people with hearing loss hear better in daily listening environments. MDHearing Smart hearing aids are designed to use the MDHearing app to adjust hearing aids to each individual's hearing loss. This study intends to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve good aided benefit, which will be compared to those fitted by audiology professionals. This study includes three components: human factor study, self-fit study, and professional-fit study. The information obtained will be useful for both audiology professionals and people with impaired hearing.

Conditions: Hearing Loss
Being tested: MDHearing smart hearing aid
Medical subject headings: Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MDHearing smart hearing aidDevice
air conduction hearing aid with app support

Study groups in NCT05165121
Study group	Role	What they receive
Human Factors	Other	The purpose of the human factor study was to verify the feasibility of self-fitting MDHearing Smart hearing aid by listeners with a mild to moderate sensorineural hearing loss. Receives: Device: MDHearing smart hearing aid
Clinical Study	Other	The clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The professional-fit group aimed to show whether the MDHearing Smart hearing aids can be fitted by audiology professional on each user reliably and if each user can benefit from using the MDHearing smart hearing aids. The self fit group intended to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve a good aided benefit. Receives: Device: MDHearing smart hearing aid

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Improvement at 1 Month as Measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12) Scale.
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement. On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation. For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation.
Measured: 1 month
Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance.
Subjects are able to use the hearing aids while using the app and manuals as guidance. Ease of use will be self reported by the subjects as to whether the task was able to be completed without guidance, able to be completed with guidance from the manual, or unable to be completed. Participants self-reported their comfort level with hearing aids and with technology in general. Participants sat with a researcher to note if tasks were able to be completed without guidance, with guidance from the manual, or unable to be completed.
This group was separate from the Self Fit group and the Professional Group.
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 202024 Sep 2021

First posted21 Dec 2021
Study start21 Sep 2020
Primary completion30 Aug 2021
Study completion24 Sep 2021

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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05165121
Sponsor's protocol ID: 1001
Status last verified: Dec 2021
First submitted: 23 Nov 2021
Last updated: 6 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids
ClinicalTrials.gov ID: NCT05165121
Acronym / sponsor ID: 1001
Conditions: Hearing Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: MDHearingAidIndustry (pharma, biotech, devices)
Collaborators: Central Michigan University
Study start: 21 Sep 2020 (actual)
Primary completion: 30 Aug 2021 (actual)
Study completion: 24 Sep 2021 (actual)
First posted: 21 Dec 2021 (actual)
Results: Posted 6 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Human Factors	Other	Device: MDHearing smart hearing aidThe purpose of the human factor study was to verify the feasibility of self-fitting MDHearing Smart hearing aid by listeners with a mild to moderate sensorineural hearing loss.
Clinical Study	Other	Device: MDHearing smart hearing aidThe clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The professional-fit group aimed to show whether the MDHearing Smart hearing aids can be fitted by audiology professional on each user reliably and if each user can benefit from using the MDHearing smart hearing aids. The self fit group intended to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve a good aided benefit.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Over 18 years old
At least one air conduction threshold above 15dB HL.
All air conduction thresholds must be under 60dB HL

Key exclusion criteria (2 listed)

Signs of outer or middle ear pathology
Greater than 60db HL hearing loss at any frequency.

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
MDHearing smart hearing aidair conduction hearing aid with app support	Device	Clinical Study, Human Factors

Primary outcome

Number of Participants With Improvement at 1 Month as Measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12) Scale.
Time frame: 1 month
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement. On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation. For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation.
Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance.
Time frame: 1 hour
Subjects are able to use the hearing aids while using the app and manuals as guidance. Ease of use will be self reported by the subjects as to whether the task was able to be completed without guidance, able to be completed with guidance from the manual, or unable to be completed. Participants self-reported their comfort level with hearing aids and with technology in general. Participants sat with a researcher to note if tasks were able to be completed without guidance, with guidance from the manual, or unable to be completed. This group was separate from the Self Fit group and the Professional Group.

Results and safety

Results posted to the registry on 6 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Human Factors	20	20
Clinical Study - Self Fit Group	36	32
Clinical Study - Professional Fit Group	35	32

Primary outcome: Number of Participants With Improvement at 1 Month as Measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12) Scale.

Time frame: 1 month. Count of participants. Unit: Participants

Measure	APHAB - Self Fit Group n = 32	APHAB - Professional Fit Group n = 32	SSQ 12 - Self Fit Group n = 32	SSQ 12 - Professional Fit Group n = 32	SSQ 12 Part B - Self Fit Group n = 32	SSQ 12 Part B - Professional Fit Group n = 32
Value	32	32	32	32	32	32

Primary outcome: Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance.

Time frame: 1 hour. Number. Unit: percentage of participants

Measure	Usability of the Hearing Aids n = 20
Value	100

Adverse events

Time frame: Adverse events were collected during the time of the study. One hour for the Human Factors portion of the study and thirty days for the Clinical Trials portion of the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Human Factors	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Clinical Study - Self-fit Group	0 of 36 (0%)	0 of 36 (0%)	0 of 36
Clinical Study - Professional-fit Group	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hearing Loss

RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
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Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
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RecruitingObservational study
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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.

Yunfang Zheng, Sc.D. CCC-A principal investigator

Central Michigan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MDHearing smart hearing aid in people with Hearing Loss, run by MDHearingAid 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 3 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 6 Jul 2023. 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 6 Jul 2023). 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?

Number of Participants With Improvement at 1 Month as Measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12) Scale. (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05165121.

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 6 Jul 2023.