Hearing Loss
Conditions
Keywords
HiResolution Bionic Ear, severe to profound hearing loss, bilateral implantation
Brief summary
Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in noisy environments. Based upon these advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants (one in each ear) and (2) compare HiResolution sound processing with conventional sound processing.
Interventions
DEVICEHiRes 90K Bionic Ear System
Cochlear implant system
Sponsors
Advanced Bionics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. No previous implant experience. 2. Age 18 years or older. 3. Postlingual onset of hearing loss. 4. Sensorineural hearing loss of a severe or greater degree in both ears. 5. Normal/patent cochlear anatomy in each ear. 6. English language proficiency. 7. Willingness and ability to participate in all scheduled procedures.
Exclusion criteria
No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users. | 8 months of bilateral cochlear implant use | Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HINT Sentences in Noise | 8 months of bilateral cochlear implant use | 20 sentences presented in noise at fixed levels |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bilaterally Implanted 31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 16 |
Baseline characteristics
| Characteristic | Bilaterally Implanted |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age Continuous | 52.6 years STANDARD_DEVIATION 12.56 |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.
Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.
Time frame: 8 months of bilateral cochlear implant use
Population: Adults with severe-to-profound hearing loss who received bilateral cochlear implants in the same operation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users. | 4.0 percent of words correct | Standard Deviation 8 |
| 8 Months Post-device Activation | Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users. | 69.0 percent of words correct | Standard Deviation 23 |
Secondary
HINT Sentences in Noise
20 sentences presented in noise at fixed levels
Time frame: 8 months of bilateral cochlear implant use