NCT04787055

Brief Summary

Study participants will be fit with previously released receiver-in-canal (RIC) hearing instruments. Participants will be asked to wear the instruments in their daily life for a minimum of 3 months, but have the option to continue to wear devices for six months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

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

August 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 21, 2023

Completed
Last Updated

April 21, 2023

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

January 28, 2021

Results QC Date

March 1, 2023

Last Update Submit

March 31, 2023

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (4)

  • Subjective Satisfaction of Hearing Aid Performance in Noisy Environments

    Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.

    Three months after initial appointment

  • Subjective Satisfaction of Hearing Aid Performance in Noisy Environments

    Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.

    Six months after initial appointment

  • Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media

    Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.

    Three months after initial appointment

  • Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media

    Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.

    Six months after initial appointment

Study Arms (2)

Receiver in the canal hearing instrument 3 month

EXPERIMENTAL

Group of subjects who will get the receiver in the canal hearing instrument and wear for period of three months.

Device: Receiver-in-canal hearing instrument

Receiver in the canal hearing instrument 6 month

EXPERIMENTAL

Group of subjects who will get the receiver in the canal hearing instrument and wear for period of six months.

Device: Receiver-in-canal hearing instrument

Interventions

Receiver-in-canal hearing instrumentDEVICE

Receiver-in-canal hearing instrument

Receiver in the canal hearing instrument 3 monthReceiver in the canal hearing instrument 6 month

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to moderate sensorineural hearing loss
  • Adult

You may not qualify if:

  • Inability or unwillingness to wear study devices for extended period of time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phonak Audiology Research Center

Aurora, Illinois, 60504, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Director of Research
Organization
Sonova US Corporate Services, LLC
phonakaudiologyresearch@gmail.com
630-821-5000

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

January 28, 2021

First Posted

March 8, 2021

Study Start

August 1, 2020

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

April 21, 2023

Results First Posted

April 21, 2023

Record last verified: 2022-05

Locations

US(1)