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

• 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: MDHearingAid
• Collaborator: Central Michigan University
• Information provided by (Responsible Party): MDHearingAid

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
Hearing Loss	Device: MDHearing smart hearing aid	Not Applicable

Study Design

• 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

Arms and Interventions

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

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

• 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

Locations

United States, Michigan

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)

Documents provided by MDHearingAid:

Study Protocol  [PDF] July 13, 2020

Statistical Analysis Plan  [PDF] June 21, 2022

More Information

• Responsible Party: MDHearingAid
• ClinicalTrials.gov Identifier: NCT05165121
• Other Study ID Numbers: 1001
• First Posted: December 21, 2021
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases