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Clinical Investigation and Validation of a Self-fitted Air-conduction Hearing Aid

NCT06167161 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-12-18

No results posted yet for this study

Summary

Approximately 48 million people in the United States have hearing loss or hearing difficulties in noisy environments. Concha Inc. is working on introducing a wireless air-conduction hearing aid to the market, featuring a self-fitting feature. Self-fitting hearing aids have emerged in recent years as a potentially viable option towards addressing unmet hearing health care needs for millions of individuals who suffer from mild-to-moderate hearing loss. The purpose of this study is to evaluate the efficiency and reliability of the self-fitting strategy developed by Concha Inc.

Conditions

Interventions

DEVICE

Hearing aid

The hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and through a dedicated smartphone application

Sponsors & Collaborators

  • University of Minnesota

    collaborator OTHER

  • San Jose State University

    collaborator OTHER

  • Concha Inc.

    lead INDUSTRY

Principal Investigators

  • Peggy Nelson, PhD · University of Minnesota

  • Anusha Yellamsetty, PhD · San Jose State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2023-05-30
Completion
2023-05-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06167161 on ClinicalTrials.gov