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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Master Umbrella Clinical Investigation will be comprised of several sub-investigations, which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Cochlear Melbourne
RECRUITING
Melbourne
HEARnet Clinical Studies
NOT_YET_RECRUITING
Melbourne
Contact Information
Primary
PRS Specialist
cltd-prs-admin@cochlear.com
+61294286555
Backup
PRS Specialist
cltd-prs-admin@cochlear.com
+612294286555
Time Frame
Start Date: 2024-02-22
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 150
Treatments
Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A)
Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B)
Using Spatial Automation Profile
Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D)
Other: Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C)
Using Spatial Automation Profile and DNR technology
Related Therapeutic Areas
Sponsors
Leads: Cochlear

This content was sourced from clinicaltrials.gov

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