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Subjective and Objective Performance With the SONNET2EAS

NCT04721990 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-08-18

No results posted yet for this study

Summary

Purpose: The purpose of this study is to demonstrate the non-inferiority and new features of an external speech processor for cochlear implant recipients.

Participants: This study seeks to enroll 15 cochlear implant recipients listening to previous technology.

Procedures (methods): Subjects will be programmed and tested with old and new technology.

Conditions

Interventions

DEVICE

Automatic Sound Management 3.0

The investigational front-end features include those within Automatic Sound Management 3.0 (i.e., Ambient Noise and Transient-Noise Reduction, and Adaptive Intelligence). Automatic Sound Management 3.0 will be accessed in the MAESTRO system software. The investigational front-end features within Automatic Sound Management 3.0 will be programmed in the SONNET2EAS processor.

Sponsors & Collaborators

  • Med-El Corporation

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Margaret T Dillon, AuD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2023-04-30
Completion
2023-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04721990 on ClinicalTrials.gov