Sensorineural Hearing Loss
Conditions
Keywords
cochlear implant, sensorineural hearing loss
Brief summary
The Fundamental Asynchronous Stimulus Timing (FAST) is a novel cochlear implant sound coding strategy. Potential benefits include improved battery life, in addition to improved localization for bilateral patients.
Detailed description
The Fundamental Asynchronous Stimulus Timing (FAST) strategy offers excellent potential as a low power alternative coding strategy to the current default strategy in Nucleus® cochlear implants, Advanced Combination Encoder (ACE). Additionally, FAST offers potential bilateral benefits - localization and listening in spatially separated noise - because it has been shown in acute, controlled studies to provide more access to interaural timing difference (ITD) cues (Smith, 2010).Previous research with experienced cochlear-implant recipients has shown issues with conversion from ACE to FAST. The FAST strategy typically sounds very different in quality, and acclimatization can be lengthy. This extended adaptation time makes it difficult to show conclusively that FAST is non-inferior to ACE for speech understanding. A potential barrier to evaluating performance with FAST in current cochlear-implant recipients is the extensive amount of prior experience that many recipients have using ACE. Hence, there is a distinct need to evaluate FAST in newly implanted recipients.
Interventions
DEVICEExperimental sound coding strategy (FAST)
Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy
DEVICECommercially available ACE sound coding strategy
Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy
Sponsors
Cochlear
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medical and audiological candidate for a unilateral CI24RE, CI512 or CI532 series implant * Post-linguistically deafened * Native speaker of American English * Eighteen years of age or older
Exclusion criteria
* Previous or existing cochlear-implant recipient * Pre-linguistically deafened (onset of hearing loss at less than two years of age) * Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array * Diagnosis of retro-cochlear pathology * Diagnosis of auditory neuropathy * Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device * Unwillingness or inability to comply with all investigational requirements * Additional cognitive handicaps that would delay rate of improvement with the cochlear implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Open Set Monosyllabic Word Recognition Score | Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months) | Open Set Monosyllabic Word Recognition is a test of 50 words each consisting of 3 individual speech sounds. The subject repeats the word s/he hears to the audiologist. The score is based on the percentage of words correct. The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for word recognition in quiet with percentage of words correct. |
| Change in Signal-to-Noise Ratio (SRT) | Visit 5 (3 Months) and Visit 8 (6 months) | The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for BKB sentences in noise with mean signal-to-noise ratio (SRT) where participants could understand 50% of sentences in noise using ACE and FAST. Lower SRT values indicate better performance. SRT measures are obtained using two types of background noise. One is Speech-Shaped Noise which is white noise or tones made to mimic speech. The other is Four-Talker Noise which is multiple talkers made to mimic background conversation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: FAST First, Then ACE Sound Processing Strategy All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy.
Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy
Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy | 6 |
| Group 2: ACE First, Then FAST Sound Processing Strategy All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 2 will be the commercially available ACE (control) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 2 will be switched to the receiving intervention of the FAST (experimental) sound coding strategy. The experimental sound coding strategy will be used from 3-6 months post activation.
Experimental sound coding strategy (FAST): Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy
Commercially available ACE sound coding strategy: Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy | 5 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Intervention (3 Months) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Group 1: FAST First, Then ACE Sound Processing Strategy | Group 2: ACE First, Then FAST Sound Processing Strategy | Total |
|---|---|---|---|
| Age, Continuous | 66.4 years | 54.36 years | 60.9 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 6 participants | 5 participants | 11 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 5 / 11 | 5 / 11 | 4 / 11 |
| serious Total, serious adverse events | 1 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Change in Open Set Monosyllabic Word Recognition Score
Open Set Monosyllabic Word Recognition is a test of 50 words each consisting of 3 individual speech sounds. The subject repeats the word s/he hears to the audiologist. The score is based on the percentage of words correct. The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for word recognition in quiet with percentage of words correct.
Time frame: Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months)
Population: Group 1 were analysed at Visit 5 for FAST sound coding strategy and at Visit 8 for ACE sound coding strategy. Group 2 were analysed at Visit 5 for ACE sound coding strategy and at Visit 8 for FAST sound coding strategy.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group 1: FAST First, Then ACE Sound Processing Strategy | Change in Open Set Monosyllabic Word Recognition Score | Visit 1 (Candidacy) - Contralateral Ear | 20.2 percentage of words correct |
| Group 1: FAST First, Then ACE Sound Processing Strategy | Change in Open Set Monosyllabic Word Recognition Score | Visit 1 (Candidacy) - Implated Ear | 5 percentage of words correct |
| Group 1: FAST First, Then ACE Sound Processing Strategy | Change in Open Set Monosyllabic Word Recognition Score | Visit 5 (3 Months) - FAST | 45 percentage of words correct |
| Group 1: FAST First, Then ACE Sound Processing Strategy | Change in Open Set Monosyllabic Word Recognition Score | Visit 8 (6 Month) - ACE | 49.5 percentage of words correct |
| Group 2: ACE First, Then FAST Sound Processing Strategy | Change in Open Set Monosyllabic Word Recognition Score | Visit 8 (6 Month) - FAST | 54 percentage of words correct |
| Group 2: ACE First, Then FAST Sound Processing Strategy | Change in Open Set Monosyllabic Word Recognition Score | Visit 1 (Candidacy) - Implated Ear | 11.8 percentage of words correct |
| Group 2: ACE First, Then FAST Sound Processing Strategy | Change in Open Set Monosyllabic Word Recognition Score | Visit 1 (Candidacy) - Contralateral Ear | 21.4 percentage of words correct |
| Group 2: ACE First, Then FAST Sound Processing Strategy | Change in Open Set Monosyllabic Word Recognition Score | Visit 5 (3 Month) - ACE | 59.4 percentage of words correct |
Primary
Change in Signal-to-Noise Ratio (SRT)
The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for BKB sentences in noise with mean signal-to-noise ratio (SRT) where participants could understand 50% of sentences in noise using ACE and FAST. Lower SRT values indicate better performance. SRT measures are obtained using two types of background noise. One is Speech-Shaped Noise which is white noise or tones made to mimic speech. The other is Four-Talker Noise which is multiple talkers made to mimic background conversation.
Time frame: Visit 5 (3 Months) and Visit 8 (6 months)
Population: Group 1 were analysed at Visit 5 for FAST sound coding strategy and at Visit 8 for ACE sound coding strategy. Group 2 were analysed at Visit 5 for ACE sound coding strategy and at Visit 8 for FAST sound coding strategy.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group 1: FAST First, Then ACE Sound Processing Strategy | Change in Signal-to-Noise Ratio (SRT) | Visit 5 - FAST (Four-Talker Noise) | 16.3 signal-to-noise ratio |
| Group 1: FAST First, Then ACE Sound Processing Strategy | Change in Signal-to-Noise Ratio (SRT) | Visit 8 - ACE(Speech-Shaped Noise) | 9.9 signal-to-noise ratio |
| Group 1: FAST First, Then ACE Sound Processing Strategy | Change in Signal-to-Noise Ratio (SRT) | Visit 8 - ACE (Four-Talker Noise) | 9.1 signal-to-noise ratio |
| Group 1: FAST First, Then ACE Sound Processing Strategy | Change in Signal-to-Noise Ratio (SRT) | Visit 5 - FAST (Speech-Shaped Noise) | 16.3 signal-to-noise ratio |
| Group 2: ACE First, Then FAST Sound Processing Strategy | Change in Signal-to-Noise Ratio (SRT) | Visit 5 - ACE(Speech-Shaped Noise) | 11.2 signal-to-noise ratio |
| Group 2: ACE First, Then FAST Sound Processing Strategy | Change in Signal-to-Noise Ratio (SRT) | Visit 5 - ACE (Four-Talker Noise) | 10.1 signal-to-noise ratio |
| Group 2: ACE First, Then FAST Sound Processing Strategy | Change in Signal-to-Noise Ratio (SRT) | Visit 8 - FAST (Speech-Shaped Noise) | 13.1 signal-to-noise ratio |
| Group 2: ACE First, Then FAST Sound Processing Strategy | Change in Signal-to-Noise Ratio (SRT) | Visit 8 - FAST (Four-Talker Noise) | 12.4 signal-to-noise ratio |