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Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects

NCT01736267 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-05-06

Study results available
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Summary

The purpose of this research study is to determine whether Auditory Brainstem Implant (ABI) can improve hearing in persons who are deaf in both ears and are not candidates for cochlear implants.

Conditions

  • Bilateral Hearing Loss for Causes Other Than Tumors

Interventions

DEVICE

Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)

Nucleus ABI541 Auditory Brainstem Implant (ABI) surgery followed by device activation, testing, and clinical assessment for five years following surgery.

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Principal Investigators

  • Daniel J Lee, MD, FACS · MEEI, HMS, MGH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2019-04-25
Completion
2019-04-25
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT01736267 on ClinicalTrials.gov