Focused Multipolar Stimulation for Hearing Loss

(SASC Trial)

Not currently recruiting at 4 trial locations

Overseen By David Kelsall, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

Disqualifiers: Previous cochlear implant, Auditory neuropathy, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to improve hearing for people with cochlear implants. The study will test different settings of a new treatment called the Focused Multipolar Stimulation (FMS) strategy to determine if they enhance hearing more effectively than the standard approach. Adults planning to receive a cochlear implant due to significant hearing loss and who can understand speech testing in the required language might be eligible. Participants will assist researchers in identifying the best settings to maximize hearing benefits. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could significantly improve cochlear implant outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this Focused Multipolar Stimulation strategy is safe for cochlear implant recipients?

Research shows that the Focused Multipolar Stimulation (FMS) method has undergone safety testing in animals. One study examined how well cats with hearing loss tolerated this method. Researchers found that long-term use of FMS did not harm the cats. While these findings are encouraging, they originate from animal studies. Limited information exists about FMS's safety for humans, as this study remains in the early stages. Currently, the main goal is to determine the best ways to use FMS, so detailed safety information for humans may not yet be available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Focused Multipolar Stimulation (FMS) for hearing loss because it offers a novel approach compared to traditional cochlear implant strategies. Unlike standard cochlear implants that typically use a single mode of stimulation, FMS uses multiple focused points of stimulation to enhance sound quality and clarity. This innovative method could potentially improve the auditory experience for cochlear implant users by providing a more natural and precise sound perception, making it a promising advancement in the field of hearing restoration.

What evidence suggests that the Focused Multipolar Stimulation strategy is effective for hearing loss?

Research has shown that Focused Multipolar Stimulation (FMS), which participants in this trial will receive, might help people with cochlear implants hear better by improving speech understanding. This technique narrows the spread of electrical signals in the inner ear, potentially making sounds clearer. Animal studies have demonstrated that FMS is safe and could benefit those with severe hearing loss. Early results suggest that FMS might improve hearing more than traditional methods. Although more research is needed, these initial findings offer promise for people with hearing loss. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with bilateral sensorineural hearing loss who are candidates for unilateral cochlear implantation, fluent in the speech testing language, and willing to follow study requirements. Excluded are those with acoustic nerve lesions, additional handicaps affecting evaluations, unrealistic expectations about the procedure's outcomes, or current participation in other interventional trials.

Inclusion Criteria

Willing and able to provide written informed consent

Fluent in the language used for speech testing

Willing to comply with all investigational requirements

Exclusion Criteria

Pregnant at the time of surgery

Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator

You have a cochlear implant now or had one in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different combinations of alternative modes and sound coding parameters for cochlear implants

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Focused Multipolar Stimulation (FMS) strategy

Trial Overview The study tests a new Focused Multipolar Stimulation (FMS) strategy against the standard Monopolar stimulation in cochlear implants. It aims to improve hearing by adjusting device parameters and fitting based on ongoing reviews within technical limits.

How Is the Trial Designed?

Group I: Adult Cochlear implant Experimental Treatment 1 Intervention

Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters

Who Is Running the Clinical Trial?

Cochlear

Lead Sponsor

Trials

96

Recruited

6,300+

Headquarters

Sydney, Australia

Dig Howitt

Cochlear

Chief Executive Officer since 2018

BE (Hons), MBA

Michael del Prado

Cochlear

Chief Medical Officer since 2022

MD, MSc, FRACP, FAAHMS, FAICD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05763342?cond=%22Hearing%20Loss,%20Bilateral%22&viewType=Table&rank=3

A Study of Objective Fitting for Focused Multipolar Stimulation FMS may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05641155

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

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5681383/

Evaluation of focused multipolar stimulation for cochlear ... The present study evaluated the long-term safety of intracochlear stimulation using FMP in a preclinical animal model of profound deafness.

4. ctv.veeva.com ctv.veeva.com/study/a-feasibility-study-evaluating-the-performance-of-focused-multipolar-stimulation-in-adult-cochlear-i

A Feasibility Study Evaluating the Performance of Focused ... This feasibility study is designed to explore several facets of hearing performance that may show improvements for alternative modes of ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28607224/

Evaluation of focused multipolar stimulation for cochlear ... The present study evaluated the long-term safety of intracochlear stimulation using FMP in a preclinical animal model of profound deafness.

6. researchgate.net researchgate.net/publication/317255431_Evaluation_of_focused_multipolar_stimulation_for_cochlear_implants_a_preclinical_safety_study

(PDF) Evaluation of focused multipolar stimulation for ... The present study evaluated the long-term safety of intracochlear stimulation using FMP in a preclinical animal model of profound deafness. Approach. Six cats ...

7. cell.com cell.com/iscience/fulltext/S2589-0042(23)01802-3

En route to sound coding strategies for optical cochlear ... Evaluation of focused multipolar stimulation for cochlear implants: a preclinical safety study ... cochlear implant hearing outcomes. Hear ...