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

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ClinicalTrials.gov Identifier: NCT05165121
Recruitment Status : Completed
First Posted : December 21, 2021
Results First Posted : July 6, 2023
Last Update Posted : July 6, 2023
Sponsor:
Collaborator:
Central Michigan University
Information provided by (Responsible Party):
MDHearingAid

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: MDHearing smart hearing aid Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids
Actual Study Start Date : September 21, 2020
Actual Primary Completion Date : August 30, 2021
Actual Study Completion Date : September 24, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Human Factors
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.
 Device: MDHearing smart hearing aid
air conduction hearing aid with app support
Clinical Study
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.
 Device: MDHearing smart hearing aid
air conduction hearing aid with app support


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Signs of outer or middle ear pathology
  • Greater than 60db HL hearing loss at any frequency.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05165121


Locations
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United States, Michigan
Central Michigan University
Mount Pleasant, Michigan, United States, 48859
Sponsors and Collaborators
MDHearingAid
Central Michigan University
Investigators
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Principal Investigator: Yunfang Zheng, Sc.D. CCC-A Central Michigan University
  Study Documents (Full-Text)

Documents provided by MDHearingAid:
Study Protocol  [PDF] July 13, 2020
Statistical Analysis Plan  [PDF] June 21, 2022

More Information
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Responsible Party: MDHearingAid
ClinicalTrials.gov Identifier: NCT05165121    
Other Study ID Numbers: 1001
First Posted: December 21, 2021    Key Record Dates
Results First Posted: July 6, 2023
Last Update Posted: July 6, 2023
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases