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NCT05165121

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

Completed NA Results posted Last updated 6 July 2023
What this trial tests

NA trial testing MDHearing smart hearing aid in Hearing Loss in 91 participants. Completed in 24 September 2021.

Timeline
21 September 2020
Primary endpoint
30 August 2021
24 September 2021

Quick facts

Lead sponsorMDHearingAid
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment91
Start date21 September 2020
Primary completion30 August 2021
Estimated completion24 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

MDHearingAid

Who can join

18 and older, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 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.

GroupValue95% CI
APHAB - Self Fit Group32
APHAB - Professional Fit Group32
SSQ 12 - Self Fit Group32
SSQ 12 - Professional Fit Group32
SSQ 12 Part B - Self Fit Group32
SSQ 12 Part B - Professional Fit Group32
Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance. Primary · 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 Profession

GroupValue95% CI
Usability of the Hearing Aids100

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Self-Fit vs. Professional-Fit Over-the-Counter Hearing Aids: A Randomized Clinical Trial.
    Zheng Y, Sepanski J, Li L. · · 2026 · PMID 42005980 · DOI 10.3766/jaaa.250047

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Other recruiting trials for Hearing Loss

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05165121.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing