Benefits of Assistive Listening Device for Speech Intelligibility

February 10, 2023 updated by: Sonova AG

Benefits of an Assistive Listening Device for Speech Intelligibility in Noise

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Hearts for Hearing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental
Participants with bilateral moderate to severe sensorineural hearing loss
Device: Roger microphone
Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids.
Device: Phonak Audeo hearing aid
Commercially available receiver-in-canal hearing aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Intelligibility in Noise
Time Frame: Day 1 of a one day study
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonova AG

Collaborators

Hearts for Hearing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 18, 2021

Primary Completion (ACTUAL)

December 13, 2021

Study Completion (ACTUAL)

December 13, 2021

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

September 28, 2021

First Posted (ACTUAL)

October 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-70

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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