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

Sponsor
MDHearingAid (Industry)
Overall Status
Completed
CT.gov ID
NCT05165121
Collaborator
Central Michigan University (Other)
91
1
2
12.1
7.5

Study Details

Study Description

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
  • Device: MDHearing smart hearing aid
N/A

Study Design

Study Type:
Interventional
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 :
Sep 21, 2020
Actual Primary Completion Date :
Aug 30, 2021
Actual Study Completion Date :
Sep 24, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Other: 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

Primary Outcome Measures

  1. Comparison of aided benefit [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. Usability of the hearing aids [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Central Michigan University Mount Pleasant Michigan United States 48859

Sponsors and Collaborators

  • MDHearingAid
  • Central Michigan University

Investigators

  • Principal Investigator: Yunfang Zheng, Sc.D. CCC-A, Central Michigan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MDHearingAid
ClinicalTrials.gov Identifier:
NCT05165121
Other Study ID Numbers:
  • 1001
First Posted:
Dec 21, 2021
Last Update Posted:
Dec 21, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2021