NCT05180630

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 28, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

November 25, 2021

Results QC Date

April 12, 2023

Last Update Submit

June 9, 2023

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (2)

  • Sound Quality of Streamed Music Rating Scale

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

    1 day

  • Own Voice Sound Quality Rating Scale

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

    1 day

Study Arms (3)

Custom earmolds, then Open domes, then Vented domes

EXPERIMENTAL

Participants first fit with Audeo 90P hearing aids and custom earmolds with dynamic venting, then fit with the same hearing aids using open domes, then fit with the same hearing aids using vented domes.

Device: Audeo P90 hearing aid with custom earmolds using dynamic ventingDevice: Audeo P90 hearing aid with Open domesDevice: Audeo P90 hearing aid with Vented domes

Open domes, then Vented domes, then Custom earmolds

EXPERIMENTAL

Participants first fit with Audeo 90P hearing aids and open domes, then fit with the same hearing aids using vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting.

Device: Audeo P90 hearing aid with custom earmolds using dynamic ventingDevice: Audeo P90 hearing aid with Open domesDevice: Audeo P90 hearing aid with Vented domes

Vented domes, then Custom earmolds, then Open domes

EXPERIMENTAL

Participants first fit with Audeo 90P hearing aids and vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting, then fit with the same hearing aids using open domes.

Device: Audeo P90 hearing aid with custom earmolds using dynamic ventingDevice: Audeo P90 hearing aid with Open domesDevice: Audeo P90 hearing aid with Vented domes

Interventions

Audeo P90 hearing aid with custom earmolds using dynamic ventingDEVICE

Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting.

Custom earmolds, then Open domes, then Vented domesOpen domes, then Vented domes, then Custom earmoldsVented domes, then Custom earmolds, then Open domes
Audeo P90 hearing aid with Open domesDEVICE

Audeo P90 hearing aid coupled with non-custom, manufacturer open domes

Custom earmolds, then Open domes, then Vented domesOpen domes, then Vented domes, then Custom earmoldsVented domes, then Custom earmolds, then Open domes
Audeo P90 hearing aid with Vented domesDEVICE

Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes

Custom earmolds, then Open domes, then Vented domesOpen domes, then Vented domes, then Custom earmoldsVented domes, then Custom earmolds, then Open domes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to severe bilateral sensorineural hearing loss
  • hearing must be symmetrical below 500 Hz
  • must live within 30 miles of Aurora IL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonova US

Aurora, Illinois, 60504, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Director of Clinical Research
Organization
Sonova USCS
phonakaudiologyresearch@gmail.com
630-821-5000

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2021

First Posted

January 6, 2022

Study Start

October 1, 2021

Primary Completion

February 28, 2022

Study Completion

April 22, 2022

Last Updated

June 28, 2023

Results First Posted

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)