A Study of Objective Fitting for Focused Multipolar Stimulation

NCT05763342 | Completed

• 1 other identifier: AI5817
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this exploratory study is to trial various objective and behavioural fitting methods for potential use with Focused Multipolar Stimulation programming.

Conditions

Hearing Loss, Bilateral

Outcome Measures

Primary Outcomes (1)

• Speech reception threshold (SRT) in noise as a signal-to-noise ratio for 50% correct score.

  Difference in speech reception threshold (SRT) between objectively fit and behaviourally fit maps using the Spanish Hearing in Noise Test (HINT) to measure the SRT, reported as a signal-to-noise ratio for 50% correct score.

  6 months

Study Arms (1)

Adult Cochlear Implant

EXPERIMENTAL

Adult cochlear implant recipients receiving different focused multipolar maps that are programmed using either behavioural or objective methods

Device: The Phoenix Research System

Interventions

The Phoenix Research System DEVICE

Focused Multipolar Stimulation (FMS) strategy in adult cochlear implant recipients.

Adult Cochlear Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderately severe to profound sensorineural hearing loss in both ears. (i.e., \>55 dB HL pure-tone average loss)
• Candidate for unilateral cochlear implantation according to locally approved criteria.
• Aged 18 years or over.
• Fluent speaker in the language used to assess speech perception performance.
• Willing and able to provide written informed consent.

You may not qualify if:

• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
• Pregnant at the time of surgery.
• Prisoners, or anyone in custody.
• Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device.
• Previous or existing cochlear-implant recipient.
• Evidence of severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.
• Duration of severe to profound hearing loss \>20 years in the ear to be implanted.
• Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
• Diagnosis of auditory neuropathy.
• Deafness due to lesions of the acoustic nerve or central auditory pathway.
• Additional handicaps that would prevent or restrict participation in the audiological evaluations.
• Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (1)

Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

MeSH Terms

Conditions

Hearing Loss, Bilateral

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: March 10, 2023
• Study Start: February 8, 2024
• Primary Completion: October 20, 2025
• Study Completion: November 26, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

ES (1)