Single Sided Deafness
Conditions
Keywords
Single sided deafness, Unilateral deafness, Unilateral hearing loss, Cochlear implantation
Brief summary
The objective of this feasibility study is to obtain preliminary safety and efficacy data associated with cochlear implantation in individuals with severe to profound sensorineural hearing loss contralateral to an ear with normal, or near-normal, hearing. The hypothesis is that restoration of hearing in the deafened ear will result in improved speech perception in the treated ear and advantages related to restoration of hearing to both ears.
Interventions
DEVICECochlear Nucleus Cochlear Implant System
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. Ability to provide informed consent. 2. Eighteen years-of-age or older at the time of implantation. 3. Presence of single-sided deafness as follows: 1. Poorer ear (ear to be implanted): * severe to profound sensorineural hearing loss, defined as pure-tone thresholds 80 dB HL or greater for the frequencies 500, 1000, 2000, 3000, and 4000 Hz. * Monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, less than or equal to 10%. 2. Better ear (contralateral ear): * Normal or near-normal hearing, defined as pure-tone thresholds no poorer than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer than 40 dB HL at 4000 Hz. * Monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, of greater than or equal to 90%. 4. Duration of severe to profound sensorineural hearing loss of at least 6 months (to ensure stability of hearing loss) but no greater than 10 years. 5. English spoken as a primary language.
Exclusion criteria
1. Alleviation of tinnitus as the stated primary or sole motivation for seeking implantation by the subject and/or investigator. 2. Actively using an implantable device in the poorer ear. 3. Onset of severe to profound hearing loss \< 6 years-of-age. 4. Evidence of active middle-ear pathology based on otologic examination and/or immittance testing. 5. Medical or psychological conditions that contraindicate undergoing surgery. 6. Ossification or any other cochlear anomaly at the implant ear that might prevent complete insertion of the electrode array. 7. Hearing loss of neural or central origin, including auditory neuropathy. 8. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations inherent to the surgical procedure and prosthetic device. 9. Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Events | 12 months | Device and procedure-related anticipated and unanticipated aderse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing in Noise Test (HINT)Score | 12 months | To access speech perception performance using Hearing in noise test sentences in noise was measured at 12 months post activation. Recorded HINT sentences were presented to participants at 60dBA pre-operatively and 12 months post activation. Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Single-Sided Deafness and a Cochlear Implant Ten subjects with Single-Sided Deafness (SSD) were implanted with a Cochlear Nucleus Cochlear Implant System and followed for 12 months after device activation. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Subjects With Single-Sided Deafness and a Cochlear Implant | — |
|---|---|---|
| Age, Continuous | 52.8 years STANDARD_DEVIATION 11.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Number of Subjects With Adverse Events
Device and procedure-related anticipated and unanticipated aderse events.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects With Single-Sided Deafness and a Cochlear Implant | Number of Subjects With Adverse Events | 1 participants |
Secondary
Hearing in Noise Test (HINT)Score
To access speech perception performance using Hearing in noise test sentences in noise was measured at 12 months post activation. Recorded HINT sentences were presented to participants at 60dBA pre-operatively and 12 months post activation. Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects With Single-Sided Deafness and a Cochlear Implant | Hearing in Noise Test (HINT)Score | 10.9 percentage of correct words. | Standard Deviation 3.8 |