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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Hearing Loss
Intervention Device: MDHearing smart hearing aid
Enrollment 91
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Human Factors Clinical Study - Self Fit Group Clinical Study - Professional Fit Group
Hide Arm/Group Description

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.

MDHearing smart hearing aid: air conduction hearing aid with app support

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 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.

MDHearing smart hearing aid: air conduction hearing aid with app support

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.

MDHearing smart hearing aid: air conduction hearing aid with app support

Period Title: Overall Study
Started 20 36 35
Completed 20 32 32
Not Completed 0 4 3
Arm/Group Title Human Factors Clinical Study - Self Fit Group Clinical Study - Professional Fit Group Total
Hide Arm/Group Description

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.

MDHearing smart hearing aid: air conduction hearing aid with app support

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 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.

MDHearing smart hearing aid: air conduction hearing aid with app support

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.

MDHearing smart hearing aid: air conduction hearing aid with app support

Total of all reporting groups
Overall Number of Baseline Participants 20 36 35 91
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 36 participants 35 participants 91 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  75.0%
20
  55.6%
20
  57.1%
55
  60.4%
>=65 years
5
  25.0%
16
  44.4%
15
  42.9%
36
  39.6%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 36 participants 35 participants 91 participants
52
(19 to 74)
62
(31 to 76)
58
(31 to 79)
52
(19 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 36 participants 35 participants 91 participants
Female
10
  50.0%
18
  50.0%
21
  60.0%
49
  53.8%
Male
10
  50.0%
18
  50.0%
14
  40.0%
42
  46.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants 36 participants 35 participants 91 participants
20
 100.0%
36
 100.0%
35
 100.0%
91
 100.0%
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APHAB - Self Fit Group APHAB - Professional Fit Group SSQ 12 - Self Fit Group SSQ 12 - Professional Fit Group SSQ 12 Part B - Self Fit Group SSQ 12 Part B - Professional Fit Group
Hide Arm/Group Description:
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). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement
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). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement.
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation.
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation.
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation.
Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Measure Type: Count of Participants
Unit of Measure: Participants
32
 100.0%
32
 100.0%
32
 100.0%
32
 100.0%
32
 100.0%
32
 100.0%
2.Primary Outcome
Title Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance.
Hide Description

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.

Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usability of the Hearing Aids
Hide Arm/Group Description:

Subjects had to complete the following tasks:

Unbox the hearing aids. Download the MDHearing Smart app to a personal smartphone. Register for the app. Place a battery in the hearing aids. Use the app to pair the hearing aids to the smartphone via Bluetooth. Use the app to take the personalization profile. Use the app to adjust the volume, program, noise reduction, microphone direction, bass, treble, and mid pitched settings.

Turn off the hearing aids.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
100
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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Human Factors Clinical Study - Self-fit Group Clinical Study - Professional-fit Group
Hide Arm/Group Description

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.

MDHearing smart hearing aid: air conduction hearing aid with app support

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 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.

MDHearing smart hearing aid: air conduction hearing aid with app support

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.

MDHearing smart hearing aid: air conduction hearing aid with app support

All-Cause Mortality
Human Factors Clinical Study - Self-fit Group Clinical Study - Professional-fit Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/36 (0.00%)   0/35 (0.00%) 
Hide Serious Adverse Events
Human Factors Clinical Study - Self-fit Group Clinical Study - Professional-fit Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/36 (0.00%)   0/35 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Human Factors Clinical Study - Self-fit Group Clinical Study - Professional-fit Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/36 (0.00%)   0/35 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sandra Porps
Organization: MDHearing
Phone: 7346572209
EMail: slp@mdhearingaid.com
Layout table for additonal information
Responsible Party: MDHearingAid
ClinicalTrials.gov Identifier: NCT05165121    
Other Study ID Numbers: 1001
First Submitted: November 23, 2021
First Posted: December 21, 2021
Results First Submitted: March 31, 2023
Results First Posted: July 6, 2023
Last Update Posted: July 6, 2023