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

NCT05165121 | Completed Results FDA Device

• 1 other identifier: 1001
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 hour

Study Arms (2)

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.

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.

Device: MDHearing smart hearing aid

Interventions

MDHearing smart hearing aid DEVICE

air conduction hearing aid with app support

Clinical Study; Human Factors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MDHearingAid: lead
• Central Michigan University: collaborator

Study Sites (1)

Central Michigan University

Mount Pleasant, Michigan, 48859, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Sandra Porps
• Organization: MDHearing

slp@mdhearingaid.com

7346572209

Study Officials

• Yunfang Zheng, Sc.D. CCC-A

  Central Michigan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 21, 2021
• Study Start: September 21, 2020
• Primary Completion: August 30, 2021
• Study Completion: September 24, 2021
• Last Updated: July 6, 2023
• Results First Posted: July 6, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)