NCT05954520

Brief Summary

The purpose of this study is to investigate the effect of nonlinear signal processing algorithms on speech perception.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 13, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

1.9 years

First QC Date

July 13, 2023

Last Update Submit

June 9, 2025

Conditions

Keywords

speech perception, hearing aids

Outcome Measures

Primary Outcomes (1)

  • Speech understanding

    Percent words correct will be measured

    1-2 hours

Secondary Outcomes (1)

  • Preference

    15 minutes

Study Arms (1)

Perceptual measures

EXPERIMENTAL

Perception will be measured for different algorithm settings and environmental variables (type of noise and signal-to-noise ratio)

Device: Tympan

Interventions

TympanDEVICE

Participants will wear a prototype hearing aid (called the Tympan)

Perceptual measures

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 18 and 65
  • Native speaker of English
  • Have bilateral, symmetric sensorineural hearing loss that is less than 75 decibels (dB) Hearing Level (HL) at 1000 Hz and below.

You may not qualify if:

  • Subjects with normal hearing, mixed hearing loss, or asymmetric sensorineural hearing loss.
  • Subjects who younger than 18 or older than 65.
  • Subjects who are not native speakers of English.
  • Subjects with thresholds more than 70 dB HL at 2000 Hz and below

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Building

Bloomington, Indiana, 47408, United States

Location

MeSH Terms

Conditions

SpeechHearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehaviorHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 20, 2023

Study Start

August 1, 2023

Primary Completion

June 9, 2025

Study Completion

June 9, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations