Trial Outcomes & Findings for Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach (NCT NCT02309099)

NCT ID: NCT02309099

Last Updated: 2019-01-07

Results Overview

Testing open-set word understanding. Recorded CNC Words lists were presented to the participant while listening to the cochlear implant alone and contralateral ear plugged/masked. Resultant score is a percentage of words correct. A higher score is better.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Intervals within the first 12 months of device use
• Results posted on: 2019-01-07

Participant Flow

Recruitment was completed in medical clinic by surgeon if a patient is identified as a potential participant and has decided to undergo vestibular schwannoma resection via a translabyrinthine surgical approach or a labyrinthectomy for Meniere's disease.

Groups were based on the participants' diagnosis (vestibular schwannoma or Meniere's disease) and subsequent surgery. Participants were initially consented into their specific group.

Participant milestones

Measure	Vestibular Schwannoma Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Overall Study STARTED	7	3
Overall Study Cochlear Implantation	7	3
Overall Study Initial Activation	7	3
Overall Study Cochlear Implant Use/Follow-Up	5	3
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Vestibular Schwannoma Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Overall Study Adverse Event	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Vestibular Schwannoma n=7 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=7 Participants	1 Participants n=3 Participants	6 Participants n=10 Participants
Age, Categorical >=65 years	2 Participants n=7 Participants	2 Participants n=3 Participants	4 Participants n=10 Participants
Sex: Female, Male Female	4 Participants n=7 Participants	2 Participants n=3 Participants	6 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=7 Participants	1 Participants n=3 Participants	4 Participants n=10 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 Participants n=7 Participants	3 Participants n=3 Participants	10 Participants n=10 Participants

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set word understanding. Recorded CNC Words lists were presented to the participant while listening to the cochlear implant alone and contralateral ear plugged/masked. Resultant score is a percentage of words correct. A higher score is better.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time 1-Month	23.6 Percentage of words correct Interval 0.0 to 72.0	22 Percentage of words correct Interval 6.0 to 44.0
Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time 3-Month	18.8 Percentage of words correct Interval 2.0 to 46.0	42.7 Percentage of words correct Interval 24.0 to 64.0
Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time 6-Month	20.4 Percentage of words correct Interval 4.0 to 34.0	48.7 Percentage of words correct Interval 36.0 to 56.0
Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time 12-Month	20.4 Percentage of words correct Interval 0.0 to 52.0	45 Percentage of words correct Interval 26.0 to 64.0

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with no background noise present. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open. Resultant score is a percentage of words correct. A higher score is better.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in Arizona Biomedical Institute (AzBio) Sentences in Quiet Scores Over Time 1-Month	98.6 Percentage of words correct Interval 97.0 to 100.0	99.7 Percentage of words correct Interval 99.0 to 100.0
Change in Arizona Biomedical Institute (AzBio) Sentences in Quiet Scores Over Time 3-Month	98.8 Percentage of words correct Interval 96.0 to 100.0	99.3 Percentage of words correct Interval 98.0 to 100.0
Change in Arizona Biomedical Institute (AzBio) Sentences in Quiet Scores Over Time 6-Month	97.8 Percentage of words correct Interval 96.0 to 99.0	99.7 Percentage of words correct Interval 99.0 to 100.0
Change in Arizona Biomedical Institute (AzBio) Sentences in Quiet Scores Over Time 12-Month	99.2 Percentage of words correct Interval 98.0 to 100.0	99.5 Percentage of words correct Interval 99.0 to 100.0

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with concurrent background noise present at 0 decibel signal-to-noise ratio (dB SNR). Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech and noise were colocated in this condition (S0N0). Resultant score is a percentage of words correct. A higher score is better.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in AzBio Sentences in Noise Scores (S0N0) Over Time 1-Month	33.2 Percentage of words correct Interval 21.0 to 45.0	44 Percentage of words correct Interval 28.0 to 54.0
Change in AzBio Sentences in Noise Scores (S0N0) Over Time 3-Month	29.4 Percentage of words correct Interval 15.0 to 52.0	41.3 Percentage of words correct Interval 24.0 to 55.0
Change in AzBio Sentences in Noise Scores (S0N0) Over Time 6-Month	30.2 Percentage of words correct Interval 19.0 to 51.0	40.3 Percentage of words correct Interval 26.0 to 54.0
Change in AzBio Sentences in Noise Scores (S0N0) Over Time 12-Month	42.2 Percentage of words correct Interval 25.0 to 59.0	50.5 Percentage of words correct Interval 47.0 to 54.0

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech was presented at 0 degrees azimuth and noise to the implanted side in this condition (S0NCI). Resultant score is a percentage of words correct. A higher score is better.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in AzBio Sentences in Noise Scores (S0NCI) Over Time 1-Month	76.6 Percentage of words correct Interval 67.0 to 88.0	84.7 Percentage of words correct Interval 77.0 to 97.0
Change in AzBio Sentences in Noise Scores (S0NCI) Over Time 3-Month	66.6 Percentage of words correct Interval 37.0 to 88.0	85 Percentage of words correct Interval 76.0 to 94.0
Change in AzBio Sentences in Noise Scores (S0NCI) Over Time 6-Month	73.4 Percentage of words correct Interval 49.0 to 94.0	83.3 Percentage of words correct Interval 70.0 to 96.0
Change in AzBio Sentences in Noise Scores (S0NCI) Over Time 12-Month	71.8 Percentage of words correct Interval 53.0 to 90.0	82.5 Percentage of words correct Interval 70.0 to 95.0

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech was presented at 0 degrees azimuth and noise to the contralateral ear in this condition (S0NContra). Resultant score is a percentage of words correct. A higher score is better.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in AzBio Sentences in Noise Scores (S0NContra) Over Time 1-Month	21.6 Percentage of words correct Interval 4.0 to 49.0	28 Percentage of words correct Interval 16.0 to 51.0
Change in AzBio Sentences in Noise Scores (S0NContra) Over Time 3-Month	12 Percentage of words correct Interval 4.0 to 24.0	38 Percentage of words correct Interval 17.0 to 50.0
Change in AzBio Sentences in Noise Scores (S0NContra) Over Time 6-Month	18 Percentage of words correct Interval 11.0 to 37.0	45 Percentage of words correct Interval 17.0 to 60.0
Change in AzBio Sentences in Noise Scores (S0NContra) Over Time 12-Month	25.4 Percentage of words correct Interval 14.0 to 38.0	49 Percentage of words correct Interval 42.0 to 56.0

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech and noise were colocated in this condition (S0N0). Resultant score is the signal-to-noise ratio in decibels (dB SNR) at which the participant scores 50% of the target words correct. A lower score is better.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in Bamford-Kowal-Bench-Speech-in-Noise (BKB-SIN) Scores (S0N0) Over Time 1-Month	-1.3 dB SNR Interval -3.0 to 0.5	-1 dB SNR Interval -2.0 to 0.5
Change in Bamford-Kowal-Bench-Speech-in-Noise (BKB-SIN) Scores (S0N0) Over Time 3-Month	-0.9 dB SNR Interval -2.5 to 1.0	-0.5 dB SNR Interval -1.0 to 0.0
Change in Bamford-Kowal-Bench-Speech-in-Noise (BKB-SIN) Scores (S0N0) Over Time 6-Month	0.9 dB SNR Interval -1.0 to 2.5	-1.83 dB SNR Interval -2.0 to -1.5
Change in Bamford-Kowal-Bench-Speech-in-Noise (BKB-SIN) Scores (S0N0) Over Time 12-Month	-0.9 dB SNR Interval -3.0 to 1.0	-2 dB SNR Interval -2.0 to -2.0

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech was presented at 0 degrees azimuth and noise to the implanted side in this condition (S0NCI). Resultant score is the signal-to-noise ratio at which the participant scores 50% of the target words correct. A lower score is better.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in BKB-SIN Scores (S0NCI) Over Time 1-Month	-3.5 dB SNR Interval -5.0 to -1.0	-6 dB SNR Interval -7.0 to -5.5
Change in BKB-SIN Scores (S0NCI) Over Time 3-Month	-3.4 dB SNR Interval -6.0 to -0.5	-5.2 dB SNR Interval -6.5 to -4.5
Change in BKB-SIN Scores (S0NCI) Over Time 6-Month	-3.3 dB SNR Interval -6.5 to -1.0	-5.33 dB SNR Interval -5.5 to -5.0
Change in BKB-SIN Scores (S0NCI) Over Time 12-Month	-4.4 dB SNR Interval -7.0 to -2.0	-5 dB SNR Interval -6.0 to -4.0

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech was presented at 0 degrees azimuth and noise to the contralateral ear in this condition (S0NContra). Resultant score is the signal-to-noise ratio at which the participant scores 50% of the target words correct. A lower score is better.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in BKB-SIN Scores (S0NContra) Over Time 1-Month	1.7 dB SNR Interval 1.0 to 3.0	-1 dB SNR Interval -2.0 to 0.5
Change in BKB-SIN Scores (S0NContra) Over Time 3-Month	1.8 dB SNR Interval 1.0 to 3.0	-2.3 dB SNR Interval -4.0 to 0.0
Change in BKB-SIN Scores (S0NContra) Over Time 6-Month	2.2 dB SNR Interval 1.0 to 3.5	-1.3 dB SNR Interval -2.5 to 0.5
Change in BKB-SIN Scores (S0NContra) Over Time 12-Month	1.2 dB SNR Interval -0.5 to 2.5	-0.25 dB SNR Interval -1.5 to 1.0

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Participants identified a speech-shaped noise source presented at various presentation levels within an 11-speaker array. Participants localized the sound source with the cochlear implant on and contralateral ear open. The RMS error (degrees) was estimated; a lower degree is more accurate/better localization of the sound source.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in Localization Root-mean-squared (RMS) Error Over Time 1-Month	40.5 Degrees Interval 30.3 to 51.2	30.7 Degrees Interval 27.0 to 32.9
Change in Localization Root-mean-squared (RMS) Error Over Time 3-Month	40.2 Degrees Interval 27.4 to 51.4	25.7 Degrees Interval 23.4 to 27.0
Change in Localization Root-mean-squared (RMS) Error Over Time 6-Month	37.5 Degrees Interval 26.2 to 55.0	21.5 Degrees Interval 18.7 to 23.1
Change in Localization Root-mean-squared (RMS) Error Over Time 12-Month	36.7 Degrees Interval 18.5 to 54.5	20.3 Degrees Interval 18.6 to 22.0

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Participants reported subjective device benefit when hearing speech in a variety of competing contexts by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. Participants based their report on daily listening with the cochlear implant on and contralateral ear open. A higher score is greater subjective benefit reported by the participant.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in Reported Subjective Benefit on the Speech Domain of the Speech, Spatial and Qualities of Hearing (SSQ) Scale Over Time 1-Month	6.2 Scores on a scale Interval 4.0 to 8.3	6.1 Scores on a scale Interval 4.0 to 7.8
Change in Reported Subjective Benefit on the Speech Domain of the Speech, Spatial and Qualities of Hearing (SSQ) Scale Over Time 3-Month	6.6 Scores on a scale Interval 5.2 to 7.8	5.8 Scores on a scale Interval 3.6 to 8.4
Change in Reported Subjective Benefit on the Speech Domain of the Speech, Spatial and Qualities of Hearing (SSQ) Scale Over Time 6-Month	6.8 Scores on a scale Interval 5.2 to 8.5	7.1 Scores on a scale Interval 6.1 to 8.4
Change in Reported Subjective Benefit on the Speech Domain of the Speech, Spatial and Qualities of Hearing (SSQ) Scale Over Time 12-Month	5.4 Scores on a scale Interval 3.1 to 7.1	7.5 Scores on a scale Interval 5.8 to 9.3

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Participants reported subjective device benefit for the directional, distance, and movement components of spatial hearing by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. Participants based their report on daily listening with the cochlear implant on and contralateral ear open. A higher score is greater subjective benefit reported by the participant.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in Reported Subjective Benefit on the Spatial Domain of the SSQ Scale Over Time 1-Month	5.4 Score on a scale Interval 2.5 to 6.9	6.4 Score on a scale Interval 6.0 to 6.9
Change in Reported Subjective Benefit on the Spatial Domain of the SSQ Scale Over Time 3-Month	6 Score on a scale Interval 4.9 to 6.8	7.5 Score on a scale Interval 6.4 to 8.5
Change in Reported Subjective Benefit on the Spatial Domain of the SSQ Scale Over Time 6-Month	5.6 Score on a scale Interval 3.9 to 6.6	7 Score on a scale Interval 6.1 to 8.9
Change in Reported Subjective Benefit on the Spatial Domain of the SSQ Scale Over Time 12-Month	5.4 Score on a scale Interval 3.1 to 7.1	7.5 Score on a scale Interval 5.8 to 9.3

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Participants reported subjective device benefit in qualities of hearing (including ease of listening and the naturalness, clarity, and identifiability of different sounds) by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. Participants based their report on daily listening with the cochlear implant on and contralateral ear open. A higher score is greater subjective benefit reported by the participant.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in Reported Subjective Benefit on the Qualities of Hearing Domain of the SSQ Scale Over Time 1-Month	6.4 Score on a scale Interval 3.0 to 10.0	5 Score on a scale Interval 3.0 to 7.0
Change in Reported Subjective Benefit on the Qualities of Hearing Domain of the SSQ Scale Over Time 3-Month	7.9 Score on a scale Interval 6.6 to 9.6	7.2 Score on a scale Interval 6.4 to 8.6
Change in Reported Subjective Benefit on the Qualities of Hearing Domain of the SSQ Scale Over Time 6-Month	6.4 Score on a scale Interval 1.6 to 9.9	7.3 Score on a scale Interval 6.4 to 8.7
Change in Reported Subjective Benefit on the Qualities of Hearing Domain of the SSQ Scale Over Time 12-Month	5.4 Score on a scale Interval 3.1 to 7.1	7.5 Score on a scale Interval 5.8 to 9.3

PRIMARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Participants reported frequency of subjective difficulty in specific listening situations. Participants based their report on daily listening with the cochlear implant on and contralateral ear open. The score is percentage of how frequently participants experience difficulty in specific listening situations, ranging from 1% (Never) to 99% (Always). A lower global score is less reported difficulty frequency by the participant.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Change in Reported Subjective Difficulty Frequency on the Abbreviated Profile of Hearing Aid Benefit (APHAB) Over Time 1-Month	23.3 Percentage of situations with difficulty Interval 9.7 to 38.7	37.8 Percentage of situations with difficulty Interval 18.5 to 66.4
Change in Reported Subjective Difficulty Frequency on the Abbreviated Profile of Hearing Aid Benefit (APHAB) Over Time 3-Month	23.3 Percentage of situations with difficulty Interval 11.0 to 39.3	25.4 Percentage of situations with difficulty Interval 12.8 to 45.8
Change in Reported Subjective Difficulty Frequency on the Abbreviated Profile of Hearing Aid Benefit (APHAB) Over Time 6-Month	27.8 Percentage of situations with difficulty Interval 5.9 to 59.4	24.6 Percentage of situations with difficulty Interval 13.7 to 31.8
Change in Reported Subjective Difficulty Frequency on the Abbreviated Profile of Hearing Aid Benefit (APHAB) Over Time 12-Month	20.1 Percentage of situations with difficulty Interval 6.5 to 35.1	16 Percentage of situations with difficulty Interval 14.3 to 17.7

SECONDARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with no background noise present. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech and noise were collocated in this condition. Resultant score is a difference in mean percentage of words correct between cochlear implant on versus off; a positive difference translates to a higher score with the cochlear implant on, whereas a negative difference translates to a lower score with the cochlear implant on.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Difference in AzBio Sentences in Quiet Scores With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 1-Month	1 Percentage correct words Interval -2.0 to 4.0	2.3 Percentage correct words Interval 0.0 to 6.0
Difference in AzBio Sentences in Quiet Scores With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 3-Month	0 Percentage correct words Interval -1.0 to 1.0	0 Percentage correct words Interval -1.0 to 1.0
Difference in AzBio Sentences in Quiet Scores With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 6-Month	0.2 Percentage correct words Interval -3.0 to 5.0	0.7 Percentage correct words Interval 0.0 to 2.0
Difference in AzBio Sentences in Quiet Scores With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 12-Month	0.6 Percentage correct words Interval 0.0 to 3.0	0.5 Percentage correct words Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech and noise were colocated in this condition (S0N0). Resultant score is a difference in the mean percentage of words correct between cochlear implant on versus off; a positive score translates to a higher score with the cochlear implant on, whereas a negative difference translates to a lower difference with the cochlear implant on.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Difference in AzBio Sentences in Noise Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 1-Month	-3.6 Percentage correct words Interval -14.0 to 15.0	1 Percentage correct words Interval 0.0 to 3.0
Difference in AzBio Sentences in Noise Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 3-Month	-2.6 Percentage correct words Interval -14.0 to 13.0	-7.7 Percentage correct words Interval -17.0 to 7.0
Difference in AzBio Sentences in Noise Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 6-Month	-6.4 Percentage correct words Interval -35.0 to 12.0	-6 Percentage correct words Interval -14.0 to 4.0
Difference in AzBio Sentences in Noise Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 12-Month	-0.4 Percentage correct words Interval -7.0 to 9.0	6 Percentage correct words Interval -8.0 to 20.0

SECONDARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech was presented at 0 degrees azimuth and noise to the implanted side in this condition (S0NCI). Resultant score is a difference in mean percentage of words correct between cochlear implant on versus off; a positive difference translates to a higher score with the cochlear implant on, whereas a negative difference translates to a lower score with the cochlear implant on.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Difference in AzBio Sentences in Noise Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 1-Month	1.6 Percentage correct words Interval -9.0 to 12.0	-1.3 Percentage correct words Interval -10.0 to 5.0
Difference in AzBio Sentences in Noise Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 3-Month	-10.2 Percentage correct words Interval -19.0 to -1.0	4.7 Percentage correct words Interval 1.0 to 9.0
Difference in AzBio Sentences in Noise Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 6-Month	4.4 Percentage correct words Interval -9.0 to 27.0	-4 Percentage correct words Interval -8.0 to 0.0
Difference in AzBio Sentences in Noise Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 12-Month	0.8 Percentage correct words Interval -7.0 to 7.0	-2 Percentage correct words Interval -9.0 to 5.0

SECONDARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech was presented at 0 degrees azimuth and noise to the contralateral ear in this condition (S0NContra). Resultant score is a difference in mean percentage of words correct between cochlear implant on versus off; a positive difference translates to a higher score with the cochlear implant on, whereas a negative difference translates to a lower score with the cochlear implant on.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Difference in AzBio Sentences in Noise Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 1-Month	10 Percentage correct words Interval 0.0 to 18.0	-2.3 Percentage correct words Interval -29.0 to 13.0
Difference in AzBio Sentences in Noise Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 3-Month	5.2 Percentage correct words Interval -7.0 to 13.0	14.7 Percentage correct words Interval 8.0 to 25.0
Difference in AzBio Sentences in Noise Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 6-Month	9.6 Percentage correct words Interval 2.0 to 20.0	12.3 Percentage correct words Interval 11.0 to 14.0
Difference in AzBio Sentences in Noise Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 12-Month	10.4 Percentage correct words Interval 6.0 to 17.0	24.5 Percentage correct words Interval 19.0 to 30.0

SECONDARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech and noise were colocated in this condition (S0N0). Resultant score is a difference in the mean signal-to-noise ratio at which the participant scores 50% of the target words correct between cochlear implant on versus off; a negative difference translates to a better score with the cochlear implant on, whereas a positive difference translates to a worse score with the cochlear implant on.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Difference in BKB-SIN Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 1-Month	-1.5 dB SNR Interval -4.0 to 1.0	-0.3 dB SNR Interval -1.5 to 0.5
Difference in BKB-SIN Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 3-Month	-0.8 dB SNR Interval -3.0 to 1.0	1 dB SNR Interval 1.0 to 1.0
Difference in BKB-SIN Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 6-Month	0.3 dB SNR Interval -1.5 to 2.0	-0.8 dB SNR Interval -1.5 to 0.5
Difference in BKB-SIN Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 12-Month	-0.6 dB SNR Interval -2.0 to 0.0	-1 dB SNR Interval -2.0 to 0.0

SECONDARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech was presented at 0 degrees azimuth and noise to the implanted side in this condition (S0NCI). Resultant score is a difference in the mean signal-to-noise ratio at which the participant scores 50% of the target words correct between cochlear implant on versus off; a negative difference translates to a better score with the cochlear implant on, whereas a positive difference translates to a worse score with the cochlear implant on.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Difference in BKB-SIN Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 1-Month	1.4 dB SNR Interval 0.5 to 2.5	-0.5 dB SNR Interval -1.0 to 0.0
Difference in BKB-SIN Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 3-Month	0.4 dB SNR Interval -1.0 to 3.0	-0.2 dB SNR Interval -1.0 to 1.5
Difference in BKB-SIN Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 6-Month	-0.6 dB SNR Interval -3.0 to 1.0	0.5 dB SNR Interval 0.0 to 1.0
Difference in BKB-SIN Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 12-Month	-1.2 dB SNR Interval -3.0 to 0.0	-1.8 dB SNR Interval -6.0 to 2.5

SECONDARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech was presented at 0 degrees azimuth and noise to the contralateral ear in this condition (S0NContra). Resultant score is a difference in the mean signal-to-noise ratio at which the participant scores 50% of the target words correct between cochlear implant on versus off; a negative difference translates to a better score with the cochlear implant on, whereas a positive difference translates to a worse score with the cochlear implant on.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Difference in BKB-SIN Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 1-Month	0.8 dB SNR Interval -0.5 to 3.0	-1.5 dB SNR Interval -2.5 to 0.0
Difference in BKB-SIN Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 3-Month	-0.4 dB SNR Interval -2.0 to 0.5	-3 dB SNR Interval -4.0 to -2.5
Difference in BKB-SIN Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 6-Month	-0.3 dB SNR Interval -1.0 to 1.5	-1.2 dB SNR Interval -2.5 to 1.5
Difference in BKB-SIN Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 12-Month	-0.5 dB SNR Interval -2.0 to 1.0	0.3 dB SNR Interval 0.0 to 0.5

SECONDARY outcome

Timeframe: Intervals within the first 12 months of device use

Population: Cochlear Implant Use/Follow-Up One participant in the Meniere's disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.

Participants identified a speech-shaped noise source presented at various presentation levels within an 11-speaker array. Participants localized the sound source with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone. The RMS error (degrees) was estimated; a lower degree is more accurate/better localization of the sound source. The resultant score reported here is a difference in mean RMS error between cochlear implant on versus off; a negative difference translates to a better score with the cochlear implant on, whereas a positive difference translates to a worse score with the cochlear implant on.

Outcome measures

Measure	Vestibular Schwannoma n=5 Participants Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 Participants Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Difference in Localization RMS Error With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 1-Month	-37.5 Degrees Interval -62.4 to -17.3	-26.8 Degrees Interval -30.2 to -24.1
Difference in Localization RMS Error With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 3-Month	-31.2 Degrees Interval -53.2 to -8.4	-41.3 Degrees Interval -61.0 to -31.3
Difference in Localization RMS Error With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 6-Month	-35.9 Degrees Interval -60.3 to -3.5	-41.5 Degrees Interval -57.3 to -30.4
Difference in Localization RMS Error With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time 12-Month	-40 Degrees Interval -62.9 to -18.4	-36.5 Degrees Interval -41.2 to -31.7

Adverse Events

Vestibular Schwannoma

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Meniere's Disease

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vestibular Schwannoma n=7 participants at risk Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 participants at risk Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Ear and labyrinth disorders Unsuccessful Initial Activation	28.6% 2/7 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.	0.00% 0/3 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.

Other adverse events

Measure	Vestibular Schwannoma n=7 participants at risk Diagnosis of vestibular schwannoma. Within the resection surgery via translabyrinthine surgical approach, cochlear implantation occurred following surgeon's visual confirmation of anatomically intact auditory nerve.	Meniere's Disease n=3 participants at risk Diagnosis of Meniere's disease. During the labyrinthectomy surgery, cochlear implantation was completed following labyrinthectomy.
Nervous system disorders Facial nerve weakness	42.9% 3/7 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.	0.00% 0/3 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.
Nervous system disorders Metallic taste on tongue on implanted side	14.3% 1/7 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.	0.00% 0/3 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.
General disorders Fever and congestion	0.00% 0/7 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.	33.3% 1/3 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.
Psychiatric disorders "Unsettling feelings" reported	0.00% 0/7 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.	33.3% 1/3 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.
Immune system disorders Nasal drainage and itching in noise	0.00% 0/7 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.	33.3% 1/3 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.
Product Issues Migration of receiver/stimulator portion of cochlear implant	14.3% 1/7 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.	0.00% 0/3 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.
Ear and labyrinth disorders Dizziness	14.3% 1/7 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.	0.00% 0/3 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.
Ear and labyrinth disorders Aural pressure	14.3% 1/7 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.	0.00% 0/3 • Data were collected from the time a participant was enrolled until the study endpoint, 12-months post-initial activation. Approximately 13 months in total for each participant. Adverse events were those events described as potential risks of the protocol. Serious adverse events were those events associated with the device that related to the rights, safety or welfare of participants.

Additional Information

Dr. Meredith Rooth

University of North Carolina at Chapel Hill

Phone: 919-966-5251

Email: meredith_rooth@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place