NCT05072470

Brief Summary

Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

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

First Submitted

Initial submission to the registry

September 28, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2021

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 2, 2022

Completed
Last Updated

February 13, 2023

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

September 28, 2021

Results QC Date

October 21, 2022

Last Update Submit

February 10, 2023

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Speech Intelligibility in Noise

    The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented.

    Day 1 of a one day study

Study Arms (1)

Experimental

EXPERIMENTAL

Participants with bilateral moderate to severe sensorineural hearing loss

Device: Roger microphoneDevice: Phonak Audeo hearing aid

Interventions

Roger microphoneDEVICE

Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids.

Experimental
Phonak Audeo hearing aidDEVICE

Commercially available receiver-in-canal hearing aid

Experimental

Eligibility Criteria

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

You may qualify if:

  • adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level)
  • experienced hearing aid users
  • symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies)
  • good written and spoken English language skills
  • healthy outer ear as confirmed by otoscopy

You may not qualify if:

  • contradictions to medical device noted upon otoscopy
  • known hypersensitivity or allergy to materials of investigational device or comparator
  • inability to produce reliable test results
  • known psychological problems
  • self reported symptoms of dizziness or vertigo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hearts for Hearing

Oklahoma City, Oklahoma, 73120, 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
Research Audiologist
Organization
Sonova USCS
phonakaudiologyresearch@gmail.com
630-821-5000

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 11, 2021

Study Start

October 18, 2021

Primary Completion

December 13, 2021

Study Completion

December 13, 2021

Last Updated

February 13, 2023

Results First Posted

December 2, 2022

Record last verified: 2021-08

Locations

US(1)