New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.

Sponsor
Cochlear
Study ID
NCT06100393
Status
Recruiting
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Conditions

  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Investigational Pre-Processing Algorithm (Sub A) — DEVICE
    DNR algorithm
  • Cochlear Limited standard-of-care pre-processing algorithms — DEVICE
    Standard-of-care sound path as implemented in the N8 system
  • Investigational Pre-Processing Algorithm (Sub B) — DEVICE
    Spatial Automation profile
  • Investigational pre-processing algorithm (Sub D) — DEVICE
    Microphone miscalibration profile with applied correction method
  • Investigational Pre-Processing Algorithm (Sub C) — DEVICE
    Spatial Automation profile and DNR algorithm
  • Investigational Pre-Processing Algorithm (Sub E) — DEVICE
    CUSP reference sound path

Study Details

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

Key Dates

First listed
Oct 25, 2023
Start date
Feb 22, 2024
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A)
  • Experimental: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B)
  • Experimental: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D)
  • Experimental: Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C)
  • Experimental: Investigational Pre-Processing Algorithm/Standard of Care pre-processing algorithm (Sub E)

Primary Outcome Measure

Australian Sentence Test in Noise (AuSTIN) [ Time Frame: 1 day - Immediately post-screening ]

Central Contacts

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