Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-12-31

Brief Summary

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The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.

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Detailed Description

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The study will be conducted as a prospective, non-controlled, non-randomized, multicenter study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study will be invited to participate in the extended follow-up. Study subjects will be followed for a minimum of 5 years post-implantation of the device.

Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Study procedures

Group Type OTHER

Electric-Acoustic Stimulation (EAS) Cochlear Implant System

Intervention Type DEVICE

Combination of a cochlear implant and a hearing aid

Interventions

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Electric-Acoustic Stimulation (EAS) Cochlear Implant System

Combination of a cochlear implant and a hearing aid

Intervention Type DEVICE

Other Intervention Names

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EAS

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older at the time of implantation
* Severe to profound sensorineural hearing loss for frequencies greater than 1500 Hz (i.e., threshold no better than 70 dB HL at 2000-8000 Hz)
* Low-frequency thresholds up to and including 500 Hz no poorer than 65 dB HL
* CNC word recognition score less than or equal to 60% in the ear to be implanted
* CNC word recognition score less than or equal to 60% in the contralateral ear
* English spoken as the primary language

Exclusion Criteria

* Conductive, retrocochlear, or central auditory disorder
* Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years
* Any physical, psychological, or emotional disorder that interferes with surgery or the ability to perform on test and rehabilitation procedures
* Developmental delays or organic brain dysfunction
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations
* Unwillingness or inability of the candidate to comply with all investigational requirements

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No