Hearing Impairment, Sensorineural
Conditions
Brief summary
The purpose of this early feasibility study is to explore several facets of hearing performance of Focused Multipolar stimulation in adult cochlear implant users.
Interventions
DEVICEFocused Multipolar Stimulation (FMS) strategy
Cochlear implant programs (A and B) that utilise FMS with sound coding enhancements
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \-
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between the Maximum C-Level for MAP A and MAP B | 10 weeks | 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. |
| Difference in Spectral Resolution (QSMD) Score Between MAP A and MAP B | 10 weeks | 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. |
| Difference in Language Independent Test (LIT) Score Between MAP A and MAP B | 10 weeks | 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. |
Countries
Belgium, United States
Participant flow
Recruitment details
All participants evaluated the experimental FMS programs (MAP A and MAP B).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 14.9 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 15 / 18 |
| serious Total, serious adverse events | 2 / 18 |
Outcome results
None listed