Improving speech clarity for adults with cochlear implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to develop and evaluate new pre-processing strategies to enhance speech perception and reduce background noise for adult cochlear implant users. It employs a master umbrella design that allows for multiple sub-investigations, each focusing on different speech enhancement algorithms. Participants will undergo assessments to determine the effectiveness of these algorithms in real-world listening situations. The study is designed to optimize the performance of cochlear implant speech processors through innovative signal processing techniques.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* User of an approved Nucleus cochlear implant.
* User of the ACE (Advanced Combination Encoder) sound processing strategy.
* Aged 18 years or older (no upper age limit).
* Able to score 20% or more at +10 dB SNR or have an adaptive Speech Recognition Threshold (SRT) of 12 dB or less CI alone on a sentence in babble test.\*
* Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
* Willing and able to provide written informed consent.
* ≥3 months post cochlear implant activation

Exclusion Criteria:

* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
* Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
* Investigator site personnel directly affiliated with this study and/or the investigator's immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Where it's running

• Cochlear Melbourne
  Melbourne, Victoria, Australia Recruiting
• HEARnet Clinical Studies
  Melbourne, Victoria, Australia Active not recruiting

Study contacts

• Study coordinator: Linty McDonald
• Email: limcdonald@cochlear.com
• Phone: +61 3 9123 6633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.