NCT05198713

Brief Summary

The present study will investigate the benefit of hearing aids for speech intelligibility (in both quiet and noisy environments) compared to the unaided condition. Participants will include adults with moderate to moderately severe hearing impairment. The participants will complete laboratory-based speech intelligibility assessments with binaural hearing aids and without hearing aids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

January 18, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 6, 2023

Completed
Last Updated

June 6, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

January 5, 2022

Results QC Date

April 12, 2023

Last Update Submit

May 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Speech Intelligibility in Quiet.

    Speech intelligibility for monosyllabic words presented in quiet. The words are presented at a fixed level and the percentage of words correctly repeated is calculated. A higher percentage is better. This was done in both unaided and aided conditions.

    Day 1 and Day 15

Secondary Outcomes (1)

  • Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words

    Day 1 and Day 15

Study Arms (1)

Experimental

EXPERIMENTAL

All participants will be fit with the study hearing aid and under go the same testing conditions.

Device: New hearing aid

Interventions

Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.

Experimental

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to moderately severe sensorineural hearing loss
  • Willingness to wear custom hearing instruments during the study.
  • Age-normal cognition
  • Ability to attend on-site study visits.

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, 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 Research
Organization
Sonova US Corporate Services, LLC

Study Officials

  • Kevin Seitz-Paquette, AuD

    Sonova AG

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 20, 2022

Study Start

January 18, 2022

Primary Completion

March 4, 2022

Study Completion

March 4, 2022

Last Updated

June 6, 2023

Results First Posted

June 6, 2023

Record last verified: 2023-05

Locations