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Degree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook

NCT04041596 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-05-29

No results posted yet for this study

Summary

The primary objective of this study is to obtain a greater understanding of the range in benefit from acoustic amplification combined with electric stimulation in cochlear implant recipients with low-frequency hearing who do not currently use the commercially approved Advanced Bionics Acoustic Earhook. The aims of this study are to 1) obtain subjective sound quality judgements of recorded speech and music samples, 2) assess vocal emotion perception, and 3) evaluate post-operative speech perception and sound field detection thresholds in CI recipients both with and without use of the acoustic ear hook.

Conditions

  • Cochlear Implant
  • Cochlear Hearing Loss

Interventions

DEVICE

Advanced Bionics' Acoustic Earhook

designed to deliver acoustic amplification through the modular attachment of the Naída CI Q90 AcoustiEarhook, while also delivering electrical stimulation along the full range of the implanted Advanced Bionics electrode.

Sponsors & Collaborators

Principal Investigators

  • Susan Waltzman, MD · New York Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2020-03-17
Completion
2020-03-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04041596 on ClinicalTrials.gov