Exploring new fitting methods for cochlear implants

An Early Feasibility, Prospective, Exploratory Study Investigating the Use of Objective Measures to Inform Focused Multipolar Fitting in Adult Cochlear Implant Recipients

This study is testing different ways to fit cochlear implants for people with hearing loss to see which method helps them hear better and is easier for doctors to use.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cochlear (Industry-sponsored)
• Locations: 1 site (Las Palmas De Gran Canaria, Las Palmas)
• Trial ID: NCT05763342 on ClinicalTrials.gov

What this trial studies

This exploratory study aims to compare various objective and behavioral fitting methods for programming Focused Multipolar Stimulation (FMS) in patients with bilateral hearing loss. The study will assess the performance of these fitting methods alongside clinician-rated experiences to identify the most effective approach that balances ease of fitting with performance outcomes. FMS is proposed as an alternative to the standard Monopolar Stimulation, potentially offering improved spectral resolution and enhanced speech perception. The study will utilize the Phoenix Research System for the interventions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and over with moderately severe to profound sensorineural hearing loss in both ears who are candidates for unilateral cochlear implantation.

Not a fit: Patients who do not have the required level of hearing loss or those who are not candidates for cochlear implantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cochlear implant programming methods that enhance speech perception for patients with hearing loss.

How similar studies have performed: While the approach of using Focused Multipolar Stimulation is innovative, similar studies have not been widely reported, indicating this may be a novel exploration.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
2. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
3. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
4. Pregnant at the time of surgery.
5. Prisoners, or anyone in custody.
6. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device.
7. Previous or existing cochlear-implant recipient.
8. Evidence of severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.
9. Duration of severe to profound hearing loss \>20 years in the ear to be implanted.
10. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
11. Diagnosis of auditory neuropathy.
12. Deafness due to lesions of the acoustic nerve or central auditory pathway.
13. Additional handicaps that would prevent or restrict participation in the audiological evaluations.
14. 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.

Where this trial is running

Las Palmas De Gran Canaria, Las Palmas

• Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria — Las Palmas De Gran Canaria, Las Palmas, Spain (Recruiting)

Study contacts

• Study coordinator: Tiago Rocha Felix

Conditions Hearing Loss, Bilateral