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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04777669
Other study ID # SBIR01
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date April 25, 2020
Est. completion date March 31, 2023

Study information

Verified date July 2022
Source York Sound Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Noise Reduction
In within subject design, listeners will have background noise removed by a noise reduction algorithm

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (2)

Lead Sponsor Collaborator
York Sound Inc NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Speech Recognition The % of words correctly understood in various noisy situations will be measured 1 day
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