New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients. (PRESENCE-MU)

Cochlear

Status: Enrolling

Conditions: Hearing Loss

Treatments: Device: Investigational Pre-Processing Algorithm (Sub B); Device: Cochlear Limited standard-of-care pre-processing algorithms; Device: Investigational Pre-Processing Algorithm (Sub A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06100393

AI5842

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A)

Other group

Treatment:

Device: Investigational Pre-Processing Algorithm (Sub A)

Device: Cochlear Limited standard-of-care pre-processing algorithms

Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B)

Other group

Description:

Using Spatial Automation Profile

Treatment:

Device: Cochlear Limited standard-of-care pre-processing algorithms

Device: Investigational Pre-Processing Algorithm (Sub B)