Cochlear Implant for Hearing Loss

(ELEVATE Trial)

Overseen By PRS Specialist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system. The system includes a microphone placed under the skin to detect speech and sound from the environment, providing the option to hear without any visible external parts. This study will involve adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). Participants will complete hearing tests and questionnaires to evaluate how well the system works and how it affects their daily life.

Are You a Good Fit for This Trial?

This trial is for adults with sensorineural hearing loss, which is caused by damage to the inner ear or auditory nerve. Participants should be able to complete hearing tests and questionnaires about how their hearing affects daily life.

Inclusion Criteria

I have significant hearing loss in one ear, confirmed by a specific hearing test.

My hearing, even with aids, scores ≤40% in word recognition tests.

Clinically established SNHL defined by a four-frequency (500, 1000, 2000 & 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥30 dB HL in the contralateral ear

Exclusion Criteria

Unable or unwilling to comply with all requirements of the clinical investigation, as determined by the investigator

Pregnant or breastfeeding women

I don't have health issues that prevent me from having surgery or anesthesia.

What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing a new totally implantable cochlear implant (TICI) system that includes an under-the-skin microphone for detecting sounds without visible external parts. Its effectiveness and impact on quality of life are being evaluated.

How Is the Trial Designed?

Group I: Totally Implantable Cochlear Implant System Experimental Treatment 1 Intervention

Participants will be implanted with the TI1132 implant

Who Is Running the Clinical Trial?

Cochlear

Lead Sponsor

Trials

96

Recruited

6,300+

Headquarters

Sydney, Australia

Dig Howitt

Cochlear

Chief Executive Officer since 2018

BE (Hons), MBA

Michael del Prado

Cochlear

Chief Medical Officer since 2022

MD, MSc, FRACP, FAAHMS, FAICD