N/A N=20 Treatment

Lab Evaluation of Novel Hearing Aid Coupling Method

Hearing Loss

Bottom Line

View on ClinicalTrials.gov: NCT05377359 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Sound Quality Ratings While Streaming — 43.15; 60.025; 64.025; 49.00 Units on a rating scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Recordings of Hearing Aids with Open Domes (Device); Recordings of Hearing Aids with Closed Domes (Device); Recordings of Hearing Aids with Novel State 1 (Device); Recordings of Hearing Aids with Novel State 2 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sonova AG
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Sound Quality Ratings While Streaming	43.15; 60.025; 64.025; 49.00; 62.9; 68.325	—
SECONDARY Situational Preference Ratings	82.225; 23.125; 50.35; 21.95; 84.225; 29.2	—

Summary

Evaluation of different hearing aid coupling methods including two states of a novel coupling method and two traditional coupling methods.

Eligibility Criteria

Inclusion Criteria

Hearing aid candidate
Meets the fitting requirements for novel and traditional coupling options
Healthy outer ear - no visible congenital or traumatic deformity
Symmetrical hearing loss
No air-bone gap greater than 10 dB at 500, 1000, 2000, and 4000 Hz
Ability to answer questions and repeat sentences
No history of problematic tinnitus or pain/discomfort from loud sounds
No history of active drainage from the ears in the past 90 days
Informed consent as documented by signature.

Exclusion Criteria

Limited mobility (not able to attend scheduled visits)
Inability to produce reliable hearing test results
History of active drainage from the ear in the previous 90 days
Abnormal appearance of the eardrum and ear canal
Known psychological problems.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05377359). 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.