High Frequency Sensorineural Hearing Loss
Conditions
Brief summary
This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.
Interventions
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
Ear to Be Implanted: * Normal to moderate hearing loss in the low frequencies with severe to profound mid to high frequency hearing loss in the ear to be implanted * CNC word recognition of 10-60% in the ear to be implanted Contralateral Ear: * Moderately severe to profound mid to high frequency hearing loss in the contralateral ear * CNC word recognition equal to or better than that in the ear to be implanted but not more than 80% correct
Exclusion criteria
* not proficient in English * unwilling and/or unable to comply with the test protocol * deafness due to lesions of the acoustic nerve or central auditory pathway. * active middle-ear disease, with or without tympanic membrane perforation. * absence of cochlear development. * duration of severe to profound hearing loss of 30 years or greater
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | From pre-operatively through 3 years post-activation of the device | The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and recorded as a total number of words correct, which will be expressed as a percentage correct for this study. The CNC word test has a score range of 0-100% with higher values indicating better scores. |
| Number of Device or Procedure Related Adverse Events | Up to 5 years post-activation of the device | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition | Pre-operatively, up to 3 years post-activation of the device | The AzBio Sentence Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nucleus Hybrid L24 Implant Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant.
Nucleus Hybrid L24 Implant | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Nucleus Hybrid L24 Implant | — |
|---|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 15.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 52 participants | — |
| Sex: Female, Male Female | 27 Participants | — |
| Sex: Female, Male Male | 25 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 52 |
| other Total, other adverse events | 35 / 52 |
| serious Total, serious adverse events | 1 / 52 |
Outcome results
Primary
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and recorded as a total number of words correct, which will be expressed as a percentage correct for this study. The CNC word test has a score range of 0-100% with higher values indicating better scores.
Time frame: From pre-operatively through 3 years post-activation of the device
Population: Data was not collected for all 52 participants at all of the time points. At 2 years post-activation, one participant doesn't have a bilateral speech score.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nucleus Hybrid L24 Implant | Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | Bilateral condition at 6 months post-activation | 29.7 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | Bilateral condition at 1 year post-activation | 31.1 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | Bilateral condition at 2 years post-activation | 32.4 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | Unilateral condition at 3 months post-activation | 31.3 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | Unilateral condition at 6 months post-activation | 35.2 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | Unilateral condition at 1 year post-activation | 35.8 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | Unilateral condition at 2 years post-activation | 35.3 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | Unilateral condition at 3 years post-activation | 36.8 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | Bilateral condition at 3 months post-activation | 26.8 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device | Bilateral condition at 3 years post-activation | 32.5 percentage of correct words |
Primary
Number of Device or Procedure Related Adverse Events
Time frame: Up to 5 years post-activation of the device
Population: Related AEs were reported up to 3 years with some participants up to 5 years as the protocol was amended from 5 to 3 year follow-up in 2022.~The data include all related AEs reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nucleus Hybrid L24 Implant | Number of Device or Procedure Related Adverse Events | Total number of device or procedure related adverse event | 98 Number of events |
| Nucleus Hybrid L24 Implant | Number of Device or Procedure Related Adverse Events | Number of serious device or procedure related adverse event | 1 Number of events |
Secondary
Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition
The AzBio Sentence Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.
Time frame: Pre-operatively, up to 3 years post-activation of the device
Population: Data was not collected for all 52 participants at all of the time points. At 1 year post-activation, one participant completed the testing at +10 dB SNR (decibel signal to noise ratio) instead of +5 dB SNR which is what is reported on.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nucleus Hybrid L24 Implant | Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition | At 3 months post-activation | 18 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition | At 6 months post-activation | 24.4 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition | At 1 year post-activation | 21.5 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition | At 2 years post-activation | 23.7 percentage of correct words |
| Nucleus Hybrid L24 Implant | Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition | At 3 years post-activation | 17.8 percentage of correct words |