NCT05180630

Sound Quality Comparisons With Different Hearing Aid Couplings and Venting Systems

Completed NA Results posted Last updated 28 June 2023

What this trial tests

NA trial testing Audeo P90 hearing aid with custom earmolds using dynamic venting in Hearing Loss, Sensorineural in 17 participants. Completed in 22 April 2022.

Timeline

1 October 2021

Primary endpoint
28 February 2022

22 April 2022

Quick facts

Lead sponsor	Sonova AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	17
Start date	1 October 2021
Primary completion	28 February 2022
Estimated completion	22 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Audeo P90 hearing aid with custom earmolds using dynamic venting
• Audeo P90 hearing aid with Open domes
• Audeo P90 hearing aid with Vented domes

Conditions studied

• Hearing Loss, Sensorineural — all drugs for Hearing Loss, Sensorineural →

Sponsor

Sonova AG — full company profile →

Who can join

Adults 18 to 80, any sex, with Hearing Loss, Sensorineural. 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.

Sound Quality of Streamed Music Rating Scale Primary · 1 day

subjective rating on scale from 0 (worst) to 100 (best) for sound quality of streamed signal

Subjective sound quality rating of streamed music with custom earmolds

Group	Value	95% CI
Custom Earmolds, Then Open Domes, Then Vented Domes	84	75 – 100
Open Domes, Then Vented Domes, Then Custom Earmolds	70	25 – 100
Vented Domes, Then Custom Earmolds, Then Open Domes	70	60 – 80

Subjective sound quality rating of streamed music using open domes

Group	Value	95% CI
Custom Earmolds, Then Open Domes, Then Vented Domes	90	80 – 100
Open Domes, Then Vented Domes, Then Custom Earmolds	62.5	25 – 100
Vented Domes, Then Custom Earmolds, Then Open Domes	80	70 – 90

Subjective sound quality rating of streamed music using vented domes

Group	Value	95% CI
Custom Earmolds, Then Open Domes, Then Vented Domes	94	84 – 100
Open Domes, Then Vented Domes, Then Custom Earmolds	81	50 – 100
Vented Domes, Then Custom Earmolds, Then Open Domes	90	80 – 100

Own Voice Sound Quality Rating Scale Primary · 1 day

subjective rating on a scale from 0 (worst) to 100 (best) for sound quality of participant's own voice quality.

Subjective rating of own voice using custom earmolds with dynamic venting

Group	Value	95% CI
Custom Earmolds, Then Open Domes, Then Vented Domes	69.2	50 – 90
Open Domes, Then Vented Domes, Then Custom Earmolds	75	55 – 90
Vented Domes, Then Custom Earmolds, Then Open Domes	40	30 – 50

Subjective rating of own voice sound quality using open domes

Group	Value	95% CI
Custom Earmolds, Then Open Domes, Then Vented Domes	80	63 – 98
Open Domes, Then Vented Domes, Then Custom Earmolds	78	50 – 100
Vented Domes, Then Custom Earmolds, Then Open Domes	50	25 – 75

Subjective rating of own voice sound quality using vented domes

Group	Value	95% CI
Custom Earmolds, Then Open Domes, Then Vented Domes	85	75 – 100
Open Domes, Then Vented Domes, Then Custom Earmolds	73	40 – 100
Vented Domes, Then Custom Earmolds, Then Open Domes	65	55 – 75

Sponsor's own description

Participants will be comparing the sound quality of their own voice and the sound quality of streamed music using universal couplings and a custom earmold with a dynamic vent.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.