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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05165121
• Other study ID #: 1001
• Status: Completed
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: September 24, 2021

Study information

• Verified date: December 2021
• Source: MDHearingAid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: September 24, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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

Locations

Country	Name	City	State
United States	Central Michigan University	Mount Pleasant	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
MDHearingAid	Central Michigan University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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