Hearing Loss, Unilateral
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
Detailed description
The study will be conducted as a single-subject, repeated measures, multi center study at 3 sites. Fifteen subjects will be enrolled in this study. Three centers in the United States and Canada will recruit subjects into this study. Study subjects will be followed for 12 months post-implantation of the device.
Interventions
Cochlear implant and audio processor
Sponsors
Med-El Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 65 years of age or older at the time of implantation * Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted * Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz * Normal or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 dB or less * Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet * Previous experience with an appropriately-fit CROS, BI-CROS, bone conduction, or traditional hearing aid, as deemed appropriate by investigator * Fluent in English
Exclusion criteria
* Duration of profound hearing loss of 10 years or more * Sudden onset of hearing loss within six months of implantation * Evidence of non-functional cochlear nerve or other retrocochlear hearing loss * Evidence of severe cochlear malformation (i.e., common cavity or ossification) * External or middle ear infection * Suspected cognitive concern * Other medical contraindication for surgery or anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the Cochlear Implant System Will be Assessed Through Speech Perception Testing in Noise Completed Through One Year (12 Months) Post Activation. | One year (12 months) post activation | The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. AzBio sentences in noise will be administered at 60 dB SPL with a signal-to-noise ratio of 0 dB SNR. Pre-operatively, sentence testing will occur with a CROS hearing aid. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise. AzBio sentences in noise are scored as a percentage of words correctly repeated back out of the total number of words presented on the list (range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the Cochlear Implant System Will be Summarized Through Speech Perception Testing in Noise Completed Through One Year (12 Months) Post Implantation. | One year (12 months) post implantation | Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 6- and 12-months post activation. AzBio sentences in noise will be administered at 60 dB SPL with a signal-to-noise ratio of 0 dB SNR. Pre-operatively, sentence testing will occur with a CROS hearing aid. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise. AzBio sentences in noise are scored as a percentage of words correctly repeated back out of the total number of words presented on the list (range of score 0-100, higher score is better). Percentage point change from baseline is reported where a positive change represents an improvement from baseline and a negative change represents a decrement from baseline. |
| Performance of the Cochlear Implant System Will be Assessed Through Speech Perception Testing in Quiet Completed Through One Year (12 Months ) Post Implantation. | One year (12 months) post implantation | Speech perception in quiet will be summarized for the CI ear at the pre-operative, 6-month, and 12-month intervals, and for the contralateral ear at the pre-operative and 12-month intervals. One 50-word CNC Words list will be used to assess speech perception in quiet at each visit, scored as the percent of words repeated correctly out of the total words presented (range of 0-100, higher is better). Percentage point change from baseline is reported where a positive change represents an improvement from baseline and a negative change represents a decrement from baseline. |
| Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation. | One year (12 months) post implantation | Subjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). The SSQ uses subjective responses to various questions related to speech, spatial, and other qualities of hearing reported on a Likert scale (range of score 0-10, higher score is a more positive subjective impression of ability or quality). Responses are averaged across the entire questionnaire for the overall score and across questions related to each subscale for individual subscale scores. Responses will be summarized from the pre-operative, 6-month, and 12-month intervals. |
Countries
Canada, United States
Participant flow
Recruitment details
Single-arm, multicenter study across three sites in the United States and Canada.
Pre-assignment details
Two participants enrolled and elected not to go through with cochlear implantation under the study. One participant enrolled and surgery was attempted, but ossification of the cochlea precluded the ability to surgically place the electrode, so the participant was withdrawn from the study. Due to the withdrawal of these three subjects prior to implantation, their enrollment slots were reallocated. This resulted in a total enrollment of 18 subjects, however, only 15 subjects were implanted.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70.1 years STANDARD_DEVIATION 4.9 |
| Age, Customized 60-64 years | 1 Participants |
| Age, Customized 65-69 years | 7 Participants |
| Age, Customized 70-74 years | 3 Participants |
| Age, Customized 75-79 years | 4 Participants |
| Hearing Loss Ear Side Left | 4 Participants |
| Hearing Loss Ear Side Right | 11 Participants |
| Region of Enrollment Canada | 5 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 15 |
| other Total, other adverse events | 3 / 18 | 2 / 15 |
| serious Total, serious adverse events | 0 / 18 | 0 / 15 |
Outcome results
None listed