Clinical trial NCT05763342: A Study of Objective Fitting for Focused Multipolar Stimulation
Official title: An Early Feasibility, Prospective, Exploratory Study Investigating the Use of Objective Measures to Inform Focused Multipolar Fitting in Adult Cochlear Implant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Bilateral
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: This study will compare various objective and behavioural fitting methods for the programming of Focused Multipolar Stimulation. Fitting methods will be assessed for both performance and clinician-rated experience to determine the most practical and beneficial method to balance ease of fitting and performance. Focused Multipolar Stimulation (FMS) is an alternative to the standard of care Monopolar Stimulation (MP). FMS may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical improvement over MP stimulation.

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.

Primary outcomes:
measure: Speech reception threshold (SRT) in noise as a signal-to-noise ratio for 50% correct score.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria
state: Las Palmas
Study officials:
References: