Loading clinical trials...

A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults | Clinical Trials | Clareo Health

NOT_YET_RECRUITING

A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults

A Post-market, Prospective, Observational Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear™ Implants in an Adult Population: a Master Umbrella Investigation

NCT07338864•Cochlear

View on ClinicalTrials.gov

Summary

The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems. Speech performance and subjective hearing results, and comparison with cochlear implant results available in literature, is intended to demonstrate the performance and clinical benefit of the cochlear implant systems investigated in this study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 18 years or older (at time of consent).
•Clinically established post-linguistic moderately severe to profound sensorineural hearing loss, in the ear to be implanted.
•Compromised functional hearing with hearing aid(s) or unlikely to receive benefit with hearing aid(s) in the ear to be implanted.
•Cochlear implant candidate as determined by the Principal Investigator. Meets local candidacy criteria for cochlear implantation.
•Candidate is a fluent speaker in the language used to assess speech perception performance.
•Willing and able to comply with study follow-up schedule.
•Willing and able to provide written informed consent.
•Candidate has access to a Smartphone compatible with Nucleus Smart App.

Exclusion Criteria

•Prior cochlear implantation in the ear to be implanted.
•Unrealistic expectations regarding the possible benefit, risks and limitations that are inherent to the surgical procedure and prosthetic device as determined by the investigator.
•Any contraindications for cochlear implantation listed in the relevant product physician's guide (to be specified per sub-investigation).
•Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
•Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as spouse, parent, child or sibling.
•Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
•Women who are pregnant.
•Current participation, or participation in an interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).

Locations (1)

University Hospital Düsseldorf

Düsseldorf, Germany

Key Dates

Start Date

April 1, 2026

Primary Completion Date

May 1, 2028

Completion Date

September 1, 2028

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Hearing LossHearing Implants

Interventions

Cochlear Nucleus Nexa Cochlear implant (CI1032)

DEVICE

Cochlear Nucleus Nexa Cochlear implant (CI1022)

DEVICE

Cochlear Nucleus Nexa Cochlear implant (CI1012)

DEVICE

Contacts

cltd-prs-admin@cochlear.com PRS Specialist

CONTACT

61 2 9428 6555 cltd-prs-admin@cochlear.com

MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY

NCT05668338

Hearing Loss

View study

RECRUITINGNA

Preschool Hearing Screening

NCT06058767

Hearing LossHearing Disorders in Children+6 more

View study

RECRUITINGNA

Evaluation of Flexible Conductive Hearing Aids

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults

Inclusion Criteria

Exclusion Criteria

MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY

Preschool Hearing Screening

Evaluation of Flexible Conductive Hearing Aids

Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III Metastatic Testicular Germ Cell Tumors

Adaptation of Pediatric Speech Audiometry Tests Into Other Languages

Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial