Ear Diseases, Hearing Disorders, Hearing Loss, Otorhinolaryngologic Diseases, Partial Deafness
Conditions
Keywords
Cochlear Implant, HiRes™ 90K Advantage implant, Cochlear Implantation, HiFocus™ Mid-Scala electrode, Listening Benefits, Adults, Cochlear Implant Benefit, Electrical Stimulation, Electro-Acoustic Stimulation (EAS)
Brief summary
The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).
Interventions
DEVICEHiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode
HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).
DEVICEEAS sound processor
Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.
Sponsors
Advanced Bionics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The two main arms are conducted in parallel. The third arm is optional for subjects who complete either of the two main arms using the EAS sound processor.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Newly Implanted Group: * Ability to provide informed consent * No previous cochlear implant experience in either ear * 18 years of age or older * Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000, 4,000, and 8,000 Hz) in the ear to be implanted * Aided CNC word recognition score up to 50% in ear to be implanted * Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear * Aided CNC word recognition score up to 80% in the contralateral ear * English language proficiency * Willingness to use an ear-level sound processor postoperatively for the duration of the study trial * Willingness to participate in all scheduled procedures outlined in the protocol
Exclusion criteria
Newly Implanted Group: * Preoperative audiometric conductive overlay of 15 dB or greater at two frequencies or more in range of 500-1000 Hz in the ear to be implanted * Congenital hearing loss (for purpose of this study, onset prior to age 2 years\*). \*Based on critical period for speech and language development * Duration greater than 30 years of severe-to-profound high-frequency hearing loss * Cochlear malformation or obstruction that would preclude full insertion of electrode array in the ear to be implanted * Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator * Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear * Active middle-ear disease/infection in the ear to be implanted * Unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures as determined by the investigator * Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator EAS Fitting Inclusion Criteria: Newly Implanted and Existing Implanted Groups * Ability to provide informed consent * 18 years of age or older, unilaterally implanted with HiRes90K™ Advantage cochlear implant with HiFocus™ Mid-Scala electrode and fit with an ear-level sound processor (i.e. Naída family device) * Postoperative unaided low frequency audiometric hearing thresholds in the treated ear up to 80 dB HL for at least one frequency from 125 - 1000 Hz * English Language Proficiency * Willingness to participate in all scheduled procedures outlined in the study protocol EAS Fitting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unaided Pure-tone Average (PTA) Hearing Threshold Measurements | Twelve months post device activation | Unaided pure tone hearing threshold measurement in the implanted ear at months 3, 6 and 12 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison) |
| Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Up to 12 months post device activation | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in quiet in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome. |
| Speech Perception Testing (AzBio) in Noise. | up to 12 months post device activation | Speech perception testing (AzBio) in noise in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome. |
Countries
United States
Participant flow
Recruitment details
Investigators recruited study subjects from their clinical practices. Thirteen study sites enrolled a total of 67 subjects. Of those enrolled, 35 completed the study main phase (month 12). The first patient first visit occurred on June 30, 2014, and last patient last visit occurred on 11/2/2020 for the main phase of the study. Twenty-four of the subjects that completed month 12 volunteered to enroll in the extended use phase. The last visit of the extended use phase was March 29, 2022.
Participants by arm
| Arm | Count |
|---|---|
| Newly Implanted Group HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor.
HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).
EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor. | 49 |
| Existing Implanted Group Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor.
EAS sound processor: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor. | 18 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Extended Use Phase | Desire to explore other commercial technology/Processor Upgrade | 11 | 1 |
| Extended Use Phase | Explanted prior to 24 month visit | 1 | 0 |
| Extended Use Phase | No longer perceiving a benefit from acoustic component | 0 | 3 |
| Extended Use Phase | Physician Decision | 1 | 0 |
| Extended Use Phase | Travel Issues | 2 | 1 |
| Extended Use Phase | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Existing Implanted Group | Total | Newly Implanted Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 32 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 35 Participants | 23 Participants |
| Age, Continuous | 60.3 years STANDARD_DEVIATION 12.37 | 64 years STANDARD_DEVIATION 14.4 | 65 years STANDARD_DEVIATION 13.95 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 18 participants | 67 participants | 49 participants |
| Sex: Female, Male Female | 6 Participants | 33 Participants | 27 Participants |
| Sex: Female, Male Male | 12 Participants | 34 Participants | 22 Participants |
| Unaided low frequency hearing threshold - EAS Baseline | 72.0 Hertz (Hz) STANDARD_DEVIATION 19.5 | 69 Hertz (Hz) STANDARD_DEVIATION 14.8 | 67 Hertz (Hz) STANDARD_DEVIATION 11 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 49 | 0 / 18 | 0 / 15 | 0 / 9 |
| other Total, other adverse events | 24 / 49 | 9 / 18 | 4 / 15 | 2 / 9 |
| serious Total, serious adverse events | 16 / 49 | 0 / 18 | 1 / 15 | 0 / 9 |
Outcome results
Primary
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in quiet in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time frame: Up to 12 months post device activation
Population: Analysis includes only subjects who completed up to month 12 using the EAS processor.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly Implanted Subjects | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Month 1 Post Device /EAS Activation | 31.3 Percent words correct | Standard Deviation 25.8 |
| Newly Implanted Subjects | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Month 6 Post Device /EAS Activation | 50.5 Percent words correct | Standard Deviation 25.6 |
| Newly Implanted Subjects | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Month 3 Post Device /EAS Activation | 50.4 Percent words correct | Standard Deviation 28 |
| Newly Implanted Subjects | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Month 12 Post Device /EAS Activation | 51.1 Percent words correct | Standard Deviation 25 |
| Newly Implanted Subjects | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Baseline | 19.3 Percent words correct | Standard Deviation 13.5 |
| Existing Implanted | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Month 12 Post Device /EAS Activation | 73.3 Percent words correct | Standard Deviation 19.2 |
| Existing Implanted | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Baseline | 61.5 Percent words correct | Standard Deviation 19.5 |
| Existing Implanted | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Month 1 Post Device /EAS Activation | 67.1 Percent words correct | Standard Deviation 17.8 |
| Existing Implanted | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Month 3 Post Device /EAS Activation | 70.5 Percent words correct | Standard Deviation 15.9 |
| Existing Implanted | Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet | Month 6 Post Device /EAS Activation | 72.7 Percent words correct | Standard Deviation 18.3 |
Primary
Speech Perception Testing (AzBio) in Noise.
Speech perception testing (AzBio) in noise in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time frame: up to 12 months post device activation
Population: Analysis includes only subjects who completed the main phase study using the EAS processor.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly Implanted Subjects | Speech Perception Testing (AzBio) in Noise. | 1 Month Post Device/ EAS Activation | 19 Percent words correct | Standard Deviation 19.7 |
| Newly Implanted Subjects | Speech Perception Testing (AzBio) in Noise. | 6 Month Post Device/ EAS Activation | 44.4 Percent words correct | Standard Deviation 28 |
| Newly Implanted Subjects | Speech Perception Testing (AzBio) in Noise. | 3 Month Post Device/ EAS Activation | 42.1 Percent words correct | Standard Deviation 28.3 |
| Newly Implanted Subjects | Speech Perception Testing (AzBio) in Noise. | 12 Month Post Device/ EAS Activation | 46.2 Percent words correct | Standard Deviation 26.3 |
| Newly Implanted Subjects | Speech Perception Testing (AzBio) in Noise. | Baseline | 11.9 Percent words correct | Standard Deviation 8.5 |
| Existing Implanted | Speech Perception Testing (AzBio) in Noise. | 12 Month Post Device/ EAS Activation | 64.1 Percent words correct | Standard Deviation 23.2 |
| Existing Implanted | Speech Perception Testing (AzBio) in Noise. | Baseline | 46.2 Percent words correct | Standard Deviation 22.6 |
| Existing Implanted | Speech Perception Testing (AzBio) in Noise. | 1 Month Post Device/ EAS Activation | 55.0 Percent words correct | Standard Deviation 27.1 |
| Existing Implanted | Speech Perception Testing (AzBio) in Noise. | 3 Month Post Device/ EAS Activation | 57.7 Percent words correct | Standard Deviation 25.8 |
| Existing Implanted | Speech Perception Testing (AzBio) in Noise. | 6 Month Post Device/ EAS Activation | 62.6 Percent words correct | Standard Deviation 27.1 |
Primary
Unaided Pure-tone Average (PTA) Hearing Threshold Measurements
Unaided pure tone hearing threshold measurement in the implanted ear at months 3, 6 and 12 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)
Time frame: Twelve months post device activation
Population: Analysis includes only subjects who completed up to month 3 using the EAS processor.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly Implanted Subjects | Unaided Pure-tone Average (PTA) Hearing Threshold Measurements | Baseline PTA | 46.7 decibles | Standard Deviation 8.7 |
| Newly Implanted Subjects | Unaided Pure-tone Average (PTA) Hearing Threshold Measurements | 3 Month PTA | 69.4 decibles | Standard Deviation 12.1 |
| Newly Implanted Subjects | Unaided Pure-tone Average (PTA) Hearing Threshold Measurements | 6 Month PTA | 67.5 decibles | Standard Deviation 12.2 |
| Newly Implanted Subjects | Unaided Pure-tone Average (PTA) Hearing Threshold Measurements | 12 Month PTA | 71.6 decibles | Standard Deviation 15.6 |
| Existing Implanted | Unaided Pure-tone Average (PTA) Hearing Threshold Measurements | 12 Month PTA | 74.5 decibles | Standard Deviation 17.1 |
| Existing Implanted | Unaided Pure-tone Average (PTA) Hearing Threshold Measurements | Baseline PTA | 72.0 decibles | Standard Deviation 19.5 |
| Existing Implanted | Unaided Pure-tone Average (PTA) Hearing Threshold Measurements | 6 Month PTA | 72.6 decibles | Standard Deviation 18.9 |
| Existing Implanted | Unaided Pure-tone Average (PTA) Hearing Threshold Measurements | 3 Month PTA | 71.6 decibles | Standard Deviation 20.5 |