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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: MDHearing smart hearing aid

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Mount Pleasant, Michigan, United States, 48859
      • Central Michigan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): September 24, 2021

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 1001 (Registro Nacional Estudios Clinicos (RNEC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes