Trial Outcomes & Findings for Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population (NCT NCT03304106)

Last Updated: 2020-10-29

Results Overview

Monosyllabic word recognition was scored in quiet using Consonant-Nucleus-Consonant (CNC) words. Scores are listed as percentage correct thus a higher score (percentage) means a better outcome.Group 1: Preoperative to postoperative percentage performance after 6 months of cochlear implant use. Group 2: Visit A to Visit B after 1 month of cochlear implant use.

Recruitment status

COMPLETED

Study phase

Target enrollment

102 participants

Primary outcome timeframe

Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month

Results posted on

2020-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Newly Implanted CI Recipients Newly implanted recipients	Existing CI Recipients Existing recipients
Overall Study STARTED	44	58
Overall Study COMPLETED	31	56
Overall Study NOT COMPLETED	13	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=31 Participants Newly implanted recipients	Group 2 n=56 Participants Existing recipients	Total n=87 Participants Total of all reporting groups
Age, Continuous	63.52 years n=31 Participants	56.98 years n=56 Participants	59.31 years n=87 Participants
Sex: Female, Male Female	15 Participants n=31 Participants	22 Participants n=56 Participants	37 Participants n=87 Participants
Sex: Female, Male Male	16 Participants n=31 Participants	34 Participants n=56 Participants	50 Participants n=87 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Duration of Hearing Loss	28.29 years n=31 Participants	28.39 years n=56 Participants	28.35 years n=87 Participants
Duration of Device Use	0 months n=31 Participants	79.30 months n=56 Participants	51.04 months n=87 Participants
Ear Tested Left	15 participants n=31 Participants	29 participants n=56 Participants	44 participants n=87 Participants
Ear Tested Right	16 participants n=31 Participants	27 participants n=56 Participants	43 participants n=87 Participants
Type of Sound Processor Kanso	0 Participants Group 1 participants had a newly implanted CI and Group 2 participants had an existing CI. Therefore the baseline measure of what Type of Sound Processor (exisiting) only applies to Group 2.	1 Participants n=56 Participants • Group 1 participants had a newly implanted CI and Group 2 participants had an existing CI. Therefore the baseline measure of what Type of Sound Processor (exisiting) only applies to Group 2.	1 Participants n=56 Participants • Group 1 participants had a newly implanted CI and Group 2 participants had an existing CI. Therefore the baseline measure of what Type of Sound Processor (exisiting) only applies to Group 2.
Type of Sound Processor N6	0 Participants Group 1 participants had a newly implanted CI and Group 2 participants had an existing CI. Therefore the baseline measure of what Type of Sound Processor (exisiting) only applies to Group 2.	49 Participants n=56 Participants • Group 1 participants had a newly implanted CI and Group 2 participants had an existing CI. Therefore the baseline measure of what Type of Sound Processor (exisiting) only applies to Group 2.	49 Participants n=56 Participants • Group 1 participants had a newly implanted CI and Group 2 participants had an existing CI. Therefore the baseline measure of what Type of Sound Processor (exisiting) only applies to Group 2.
Type of Sound Processor N7	0 Participants Group 1 participants had a newly implanted CI and Group 2 participants had an existing CI. Therefore the baseline measure of what Type of Sound Processor (exisiting) only applies to Group 2.	6 Participants n=56 Participants • Group 1 participants had a newly implanted CI and Group 2 participants had an existing CI. Therefore the baseline measure of what Type of Sound Processor (exisiting) only applies to Group 2.	6 Participants n=56 Participants • Group 1 participants had a newly implanted CI and Group 2 participants had an existing CI. Therefore the baseline measure of what Type of Sound Processor (exisiting) only applies to Group 2.

PRIMARY outcome

Timeframe: Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month

Population: All participants with complete data set

Outcome measures

Outcome measures
Measure	Group 1 n=31 Participants Newly implanted recipients	Group 2 n=56 Participants Existing recipients
Change in Monosyllabic Word Recognition Scores (CNC) in Quiet Pre-operative/Visit A	13.9 percentage of correct words Standard Deviation 15.2	60.1 percentage of correct words Standard Deviation 23
Change in Monosyllabic Word Recognition Scores (CNC) in Quiet 6-Month	60.2 percentage of correct words Standard Deviation 17.2	—
Change in Monosyllabic Word Recognition Scores (CNC) in Quiet Visit B (1-Month)	—	59.1 percentage of correct words Standard Deviation 22

Adverse Events

Group 1

Serious events: 5 serious events

Other events: 17 other events

Deaths: 0 deaths

Group 2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=31 participants at risk Newly implanted recipients	Group 2 n=56 participants at risk Existing recipients
Cardiac disorders Hospitalization secondary to losing consciousness from sinus bradycardia	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
General disorders Hospitalization	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Nervous system disorders Parkinson's disease diagnosis	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Infections and infestations Hospitalization for sepsis	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Dizziness	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Vertigo and BPPV	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Cardiac disorders Abnormal heart rhythm requiring placement of pacemaker	0.00% 0/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	1.8% 1/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)

Other adverse events

Additional Information

Laura Chenier, Clinical Project Manager

Cochlear Limited

Phone: 422-325-4171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The disclosure restriction on the PIs, restricts sites from publishing site data or study data without sponsor review and approval.
Publication restrictions are in place

Restriction type: OTHER

Measure	Group 1 n=31 participants at risk Newly implanted recipients	Group 2 n=56 participants at risk Existing recipients
Ear and labyrinth disorders Dizziness and imbalance	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Injury, poisoning and procedural complications Tongue numbness/mouth numbness	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Nervous system disorders Headaches	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Tinnitus	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Vertigo	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Injury, poisoning and procedural complications Change in taste	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Loss of hearing	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Injury, poisoning and procedural complications MAP too loud, unable to wear within 48hours of activation	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Swelling at CI site (Ear not specified)	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Injury, poisoning and procedural complications Altered taste post-op	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Occasional dizziness	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Infections and infestations Sinus infection	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Skin and subcutaneous tissue disorders Diffuse photodamage of the skin	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
General disorders Jaw soreness	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Pain behind left ear	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Injury, poisoning and procedural complications Swelling in face and neck	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
General disorders A window blind fell and hit head causing pain on head and neck	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Tinnitus began night of surgery after a window blind fell on head	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Infections and infestations Tooth Abscess	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
General disorders Lip swelling	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Musculoskeletal and connective tissue disorders Arthritis of carpometacarpal joint on left thumb	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Nervous system disorders Pinched nerve in back causing pain down right leg	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Injury, poisoning and procedural complications Left ear tinnitus following surgery	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Increased tinnitus	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Injury, poisoning and procedural complications Redness and swelling on implanted ear	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Intermittent dizziness	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Right ear pain	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Injury, poisoning and procedural complications Spitting suture at cochlear implant incision site	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Nervous system disorders Left facial pain	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
General disorders Fatigue post-surgery	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Ear and labyrinth disorders Tingling, numbing and slight pain at coil/magnet site on head	3.2% 1/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	0.00% 0/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Injury, poisoning and procedural complications Patient experienced uncomfortable loudness	0.00% 0/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	1.8% 1/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Injury, poisoning and procedural complications Flinching to high frequency stimulation	0.00% 0/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	1.8% 1/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Injury, poisoning and procedural complications Loudness discomfort and increased tinnitus	0.00% 0/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	1.8% 1/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
General disorders Right lower abdominal pain	0.00% 0/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	1.8% 1/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Musculoskeletal and connective tissue disorders Hammer toe surgery left foot	0.00% 0/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	1.8% 1/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)
Injury, poisoning and procedural complications MAP too loud; decreased speech perception in noise	0.00% 0/31 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)	1.8% 1/56 • Time of enrollment through 6 months post-operatively (Group 1) and time of enrollment through 1 month follow-up (Group 2)