Improving speech clarity for adults with cochlear implants
A Feasibility, Prospective, Repeated-measures Investigation of Hearing Outcomes With New Pre-processing Speech Enhancement Algorithms Compared to Standard-of-care Algorithms in Adult Cochlear Implant Recipients: a Master Umbrella Investigation
This study is testing new ways to improve how well adults with cochlear implants can understand speech in noisy environments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cochlear Industry-sponsored |
| Locations | 2 sites (Melbourne, Victoria and 1 other locations) |
| Trial ID | NCT06100393 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are users of an approved Nucleus cochlear implant and have a certain level of speech recognition ability.
Not a fit: Patients who do not meet the eligibility criteria or have additional health factors that restrict participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the speech understanding and overall quality of life for cochlear implant recipients.
How similar studies have performed: Other studies have shown promise in enhancing speech perception for cochlear implant users through advanced signal processing techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Melbourne, Victoria and 1 other locations
- Cochlear Melbourne — Melbourne, Victoria, Australia (Recruiting)
- HEARnet Clinical Studies — Melbourne, Victoria, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Linty McDonald
- Email: limcdonald@cochlear.com
- Phone: +61 391236633
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.