A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults. (SASC)

An Early Feasibility, Prospective, Exploratory Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding Enhancements in Adult Cochlear Implant Recipients (SASC).

The purpose of this early feasibility study is to explore several facets of hearing performance of Focused Multipolar stimulation in adult cochlear implant users.

Study Overview

• Status: Completed
• Conditions: Hearing Impairment, Sensorineural
• Intervention / Treatment: Device: Focused Multipolar Stimulation (FMS) strategy

Detailed Description

Alternative modes of stimulation will be investigated that may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical benefits over MP stimulation. The purpose of this study is to balance the clinical improvements of alternative modes of stimulation with technical and usability requirements for power usage. By iteratively evaluating different sets of stimulation and sound coding parameters, this study will determine device settings and fitting techniques. Measures of speech recognition, listening effort, neural responses, electrode placement, battery life, and usability acceptance will be obtained to evaluate clinical benefits

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven
    • Leuven, Leuven, Belgium, 3000
      • Universitair Ziekenhuis Leuven
  • Mechelen
    • Mechelen, Mechelen, Belgium, B-2800
      • Cochlear Technology Centre Belgium
  • Wilrijk
    • Wilrijk, Wilrijk, Belgium, 2610
      • ENT Department, Sint-Augutinus Antwerp
• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Rocky Mountain Ear Center
    • Lone Tree, Colorado, United States, 80124
      • Denver Research and Technology Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1) Candidate for unilateral cochlear implantation according to bilateral sensorineural hearing loss criteria, who has decided to proceed with implantation through routine processes.

a) Bilateral sensorineural hearing loss criteria for clinics in the United States: i) Ear to be implanted:

1. Moderate to profound sensorineural hearing loss, defined as a pure-tone average (PTA) (250 - 1000 Hz) ≥ 40 dB HL and a PTA (2000 - 8000 Hz) ≥ 65 dB HL
2. Aided word score ≤ 40% ii) Contralateral ear:

(1) PTA (500, 1000, 2000, and 4000 Hz) > 30 dB HL (2) Aided word score ≤ 80% b) Bilateral sensorineural hearing loss criteria for clinics in Belgium: i) Both ears:

1. PTA (500, 1000, 2000, and 4000 Hz) ≥ 70 dB HL for average of 3 out of 4 frequencies
2. Unaided phoneme score ≤ 50% on CVC in quiet at 70 dB SPL in free field
3. ABR peak ≥ 75 dB nHL

2) 18 years of age or older.

3) Fluent in the language used for speech testing.

4) Willing to comply with all investigational requirements.

5) Willing and able to provide written informed consent

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Exclusion Criteria:

1. Previous or existing cochlear-implant recipient.
2. Severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.
3. Duration of severe to profound hearing loss > 20 years in the ear to be implanted.
4. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
5. Diagnosis of auditory neuropathy.
6. Deafness due to lesions of the acoustic nerve or central auditory pathway.
7. Pregnant at the time of surgery.
8. Additional handicaps that would prevent or restrict participation in the audiological evaluations.
9. 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.
10. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
11. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
12. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
13. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cochlear implant user; Adult cochlear implant users assessing different Focused Multipolar Stimulation (FMS) programs	Device: Focused Multipolar Stimulation (FMS) strategy; Cochlear implant programs (A and B) that utilise FMS with sound coding enhancements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference Between the Maximum C-Level for MAP A and MAP B	Difference between the maximum comfortable loudness level C-Level for MAP A and MAP B. This is the maximum current level that provides loud but comfortable sound level for the cochlear implant user.	10 weeks
Difference in Spectral Resolution (QSMD) Score Between MAP A and MAP B	Mean difference between MAP A and MAP B for Quick Spectral Modulation Detection (QSMD) test. Higher scores indicate better spectral resolution and generally better ability to distinguish acoustic spectral patterns important for speech understanding. It measures the minimum modulation depth that can be perceived to enable discrimination of a spectrally modulated noise from a flat spectrum noise with the same bandwidth and overall intensity level.	10 weeks
Difference in Language Independent Test (LIT) Score Between MAP A and MAP B	Mean difference between MAP A and MAP B for the phoneme discrimination test, Language independent test (LIT). The LIT test measures how well a person can hear the difference between speech sounds by asking them to identify which sound is different from the others.	10 weeks

Collaborators and Investigators

• Sponsor: Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2023
• Primary Completion (Actual): February 6, 2025
• Study Completion (Actual): December 8, 2025

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Sensorineural
• Other Study ID Numbers: AI5781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No