Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2023-11-01

Brief Summary

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The purpose of this investigation is to demonstrate the safety and effectiveness of MED-EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA-approved candidacy criteria and, yet, continue to demonstrate insufficient functional access to sound with appropriately fit hearing aids and aural habilitation.

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Detailed Description

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Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Multicenter, open-label, non-randomized, repeated-measures design with two study arms as follows. Prospective: interventional study arm with prospective enrollment and treatment through one year of implant use. Retrospective: observational study arm with retrospective protocol for systematic chart review of patients with at least one year of implant use.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prospective

Detailed interventions and outcome measures refer to the prospective, experimental study arm. The prospective arm is active but not enrolling.

Group Type EXPERIMENTAL

MED-EL SYNCHRONY PIN Cochlear Implant

Intervention Type DEVICE

Subjects will be implanted with the MED-EL SYNCHRONY PIN Cochlear Implant System with +FLEX24, +FLEX28, +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO 2 (single-unit) external audio processors.

Retrospective

Study identification, sponsor/collaborators, oversight, purpose, indications, and primary endpoints for the retrospective, observational study arm align with the prospective study arm. The retrospective arm will be enrolling by invitation for chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020. The specific devices and outcome measures will vary slightly for retrospective subjects, based on what was clinically available and used at the time of implantation.

Group Type OTHER

Cochlear Implant

Intervention Type OTHER

Chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020.

Interventions

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MED-EL SYNCHRONY PIN Cochlear Implant

Subjects will be implanted with the MED-EL SYNCHRONY PIN Cochlear Implant System with +FLEX24, +FLEX28, +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO 2 (single-unit) external audio processors.

Intervention Type DEVICE

Cochlear Implant

Chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020.

Intervention Type OTHER

Other Intervention Names

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SYNCHRONY +FLEXSOFT SYNCHRONY +FLEX28 SYNCHRONY +FLEX24

Eligibility Criteria

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Inclusion Criteria

* Children 7 months to 5 years 11 months of age at the time of implantation
* Bilateral, severe to profound sensorineural hearing loss (SNHL) in the high frequencies and

* For subjects implanted under 12 months of age: bilateral, severe to profound SNHL in the low frequencies
* For subjects implanted at 12 months to 5 years 11 months of age: bilateral, mild to profound sensorineural hearing loss in the low frequencies
* Insufficient functional access to sound with appropriately fit amplification and aural habilitation
* Objective measures consistent with repeatable unaided audiometric thresholds for subjects under 12 months of age
* Radiologic evidence of potential for full insertion with one of the included electrode arrays
* Ability to undergo general anesthesia
* At least one parent/guardian who is fluent in one of the available languages of the LEAQ
* Parental commitment to study parameters

Exclusion Criteria

* Magnetic Resonance Imaging (MRI) evidence of cochlear nerve deficiency
* Active middle ear infection
* Permanent conductive hearing loss
* Treatable mixed hearing loss
* Current or history of meningitis
* Common cavity
* Skin or scalp condition precluding use of external audio processor
* Suspected cognitive impairment, organic brain dysfunction, or syndromic etiology that may affect performance
* ASA (American Society of Anesthesiologists) Class 3 or higher in subjects under 12 months of age
* History of prior use of a hearing implant
* Unrealistic parental/patient expectations
* Child is not able to complete speech perception testing in English

Minimum Eligible Age

7 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No