Removing Background Talker Noise for Cochlear Implant Users

July 11, 2022 updated by: York Sound Inc

When hearing-impaired listeners are properly aided with a hearing aid (HA) or cochlear implant (CI), they are often able to comfortably maintain a conversation in quiet environments. However, in group environments, such as a large family dinner, restaurant, or other environment where multiple people are talking simultaneously, hearing-impaired listeners have great difficulty participating in conversations and frequently withdraw or avoid the situation. As such, it would be highly beneficial to implement an algorithm into HAs or CIs to remove background talkers ("babble") from the signal to reduce listening effort for the hearing-impaired listener and allow them to converse as if they were in a quiet environment. Although HAs and CIs frequently incorporate noise reduction algorithms, these algorithms are not effective when the background is babble. The problem of removing babble involves segregating speech from speech. Hence, the spectral properties of the signal and noise are extremely similar.

Despite these challenges, we developed an algorithm to remove background babble. In the following study will test the ability of cochlear implant users to understand speech with background babble noise using our noise reduction algorithm or no noise reduction algorithm. We hypothesize that CI users will be able to understand significantly more speech in babble noise when using our algorithm.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

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

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects with CIs 12 years of age and older with no diagnosis of other communicative or cognitive disorders. Subjects must have native or native-like English proficiency.

Exclusion Criteria:

No diagnosed cognitive or communicative disorders (other than hearing loss), presence of acute/chronic otitis media, useable acoustic hearing, and non-English speaking.

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experiment
Subjects will be tested for their ability to understand speech with and without noise reduction
Other: Noise Reduction
In within subject design, listeners will have background noise removed by a noise reduction algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Recognition
Time Frame: 1 day
The % of words correctly understood in various noisy situations will be measured
1 day

Collaborators and Investigators

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

Sponsor

York Sound Inc

Collaborators

NYU Langone Health

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)

April 25, 2020

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBIR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data requests will be considered on a case by case basis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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