PMCF on Safety and Performance of HiResTM Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss

  • STATUS
    Recruiting
  • days left to enroll
    32
  • participants needed
    30
  • sponsor
    Advanced Bionics AG
Updated on 29 November 2021
AIDS
hard of hearing
audiogram

Summary

This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM MS Electrode and HiResTM Ultra 3D Cl HiFocusTM MS Electrode (Ultra X) under normal conditions of use as it is approved for this device.

Description

This study is set up to document any adverse events and comparing pre- to post-implant benefit to subjects. Any adverse events associated with the device will be documented via Advanced Bionics complaint handling system for the lifetime of the device. A within-subjects repeated-measures design will be employed. Speech perception will be evaluated preoperatively with conventional amplification to determine candidacy and to establish baseline performance. Efficacy parameters are speech perception data which will be collected according to clinical routine with a 6 month follow up period. Subjects will be implanted unilaterally with the Ultra X according to standard clinical care.

The primary efficacy objective is to demonstrate that mean monosyllabic word recognition score with the Ultra X used in combination with a sound processor programmed with the latest fitting software six months after activation is at least 20% better than the mean word score at baseline with conventional amplification in the same ear.

The primary efficacy endpoint is reached six months after device activation.

Details
Condition Sensorineural hearing loss, Hearing Loss, Auditory Loss and Deafness, Hearing Impairment
Treatment cochlear implantation
Clinical Study IdentifierNCT04610112
SponsorAdvanced Bionics AG
Last Modified on29 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

No previous experience with any auditory implant
years of age or older
Postlingual onset of severe hearing loss ( 4 years of age)
Limited benefit from appropriately fitted hearing aids, defined as scoring 60% or less in Freiburger Monosyllabic word test
German language proficiency
Willingness to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria

Cochlear malformation or obstruction that would preclude full insertion of electrode array
Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures
Evidence of central auditory lesion or compromised auditory nerve
Pregnancy at time of surgery
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note