Focused Multipolar Stimulation for Hearing Loss

(SASC Trial)

Recruiting at 4 trial locations

Overseen By Taike Bruyneel

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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Focused Multipolar Stimulation (FMS) for hearing loss?

Focused Multipolar Stimulation (FMS) has been shown to create more precise patterns of neural activation in cochlear implants, which could improve speech perception by reducing interference between stimulation channels. This approach has demonstrated the ability to produce more localized neural responses, suggesting potential benefits for individuals with hearing loss. ^{1 2 3 4 5}

Is focused multipolar stimulation safe for humans?

A preclinical study on animals evaluated the long-term safety of focused multipolar stimulation for cochlear implants, but no human safety data is provided in the available research. ^{1 2 3 6 7}

How does the Focused Multipolar Stimulation treatment for hearing loss differ from other treatments?

Focused Multipolar Stimulation (FMS) is unique because it uses multiple current sources to create highly focused patterns of neural activation, which can improve speech perception by reducing interaction between stimulating channels compared to traditional cochlear implants that use a single current source. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing new methods for sending sound signals through cochlear implants to help people with severe hearing loss. The goal is to improve how well users can understand speech by making the electrical signals more precise. Researchers will adjust and test different settings to find the best ones for better hearing performance and usability. Cochlear implants are medical devices that electrically stimulate the auditory nerve to help deaf and severely hearing-impaired individuals hear again.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of focused multipolar stimulation for cochlear implants: a preclinical safety study. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Focused electrical stimulation using a single current source. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of focused multipolar stimulation for cochlear implants in long-term deafened cats. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Magnetic stimulation allows focal activation of the mouse cochlea. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Thin-film micro-electrode stimulation of the cochlea in rats exposed to aminoglycoside induced hearing loss. [2016]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Auditory brainstem implant in posttraumatic cochlear nerve avulsion. [2004]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Hearing rehabilitation in neurofibromatosis type 2 patients: cochlear versus auditory brainstem implantation. [2022]