NCT06100393

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a feasibility, prospective, multi-center, single-subject, repeated-measures clinical investigation in experienced adult cochlear implant users. The Master Umbrella design will enable the execution of a series of sub-investigations in the same user population, with the goal to evaluate a range of speech enhancement pre-processing algorithms in separate sub-investigations. The primary objectives for each sub-investigation will be consistent with the master umbrella investigation, with secondary and exploratory objectives selected based on the algorithm to be investigated. Secondary and exploratory objectives will be described in the sub-investigation documentation.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Investigational Pre-Processing Algorithm (Sub A)	The algorithms act upon the digital audio signal received by the microphones and other sensors to enhance speech and attenuate noise prior to encoding the signal for delivery to a cochlear implant via the specified system.
DEVICE	Cochlear Limited standard-of-care pre-processing algorithms	Automatic Gain Control, SNR-NR, Forward Focus
DEVICE	Investigational Pre-Processing Algorithm (Sub B)	Spatial Automation profile
DEVICE	Investigational pre-processing algorithm (Sub D)	Microphone miscalibration profile with applied correction method
DEVICE	Cochlear Limited standard-of-care pre-processing algorithms	Standard microphone calibration profile
DEVICE	Investigational Pre-Processing Algorithm (Sub C)	Spatial Automation profile and DNR algorithm

Timeline

• Start date: 2024-02-22
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2023-10-25
• Last updated: 2025-12-05

Locations

2 sites across 1 country: Australia