N/A N=91 Randomized Other

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

Hearing Loss

Bottom Line

View on ClinicalTrials.gov: NCT05165121 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: 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. — 32; 32; 32; 32 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MDHearing smart hearing aid (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MDHearingAid
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
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.	32; 32; 32; 32; 32; 32	—
PRIMARY Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance.	100	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05165121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.