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Trial Outcomes & Findings for Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults (NCT NCT02638883)

NCT ID: NCT02638883

Last Updated: 2022-09-27

Results Overview

Two CNC( consonant-nucleus-consonant) Word lists (Peterson \& Lehiste, 1962) were administered in quiet at a level of 60 dBA in the sound-field and scored as a total number of words correct, expressed as a percentage. Possible score are range from 0% to 100 % words correctly repeated. Higher scores mean a better outcome.

Recruitment status

COMPLETED

Target enrollment

6 participants

Primary outcome timeframe

12 months

Results posted on

2022-09-27

Participant Flow

Participant milestones

Participant milestones
Measure
Implanted
Subjects will be implanted with the Hybrid SRW cochlear implant. Hybrid SRW cochlear implant: Subjects will be implanted with the Hybrid SRW
Overall Study
STARTED
6
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
0

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
Implanted
n=6 Participants
Subjects will be implanted with the Hybrid SRW cochlear implant. Hybrid SRW cochlear implant: Subjects will be implanted with the Hybrid SRW
Age, Customized
6 Participants
n=6 Participants
Sex: Female, Male
Female
3 Participants
n=6 Participants
Sex: Female, Male
Male
3 Participants
n=6 Participants
Region of Enrollment
United States
6 participants
n=6 Participants
Age at Implant in Years
57.5 years
STANDARD_DEVIATION 11.0 • n=6 Participants
Duration of Hearing Loss
37.8 years
STANDARD_DEVIATION 25.2 • n=6 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Only 5 subjects were analysed rather than 6 as one subject used electric mode only by 12 months post activation.

Two CNC( consonant-nucleus-consonant) Word lists (Peterson \& Lehiste, 1962) were administered in quiet at a level of 60 dBA in the sound-field and scored as a total number of words correct, expressed as a percentage. Possible score are range from 0% to 100 % words correctly repeated. Higher scores mean a better outcome.

Outcome measures

Outcome measures
Measure
Implanted
n=5 Participants
Subjects will be implanted with the Hybrid SRW cochlear implant. Hybrid SRW cochlear implant: Subjects will be implanted with the Hybrid SRW
CNC (Consonant-nucleus-consonant) Words
64.8 percentage of correct words.
Standard Deviation 23.0

Adverse Events

Implanted

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Implanted
n=6 participants at risk
Subjects will be implanted with the Hybrid SRW cochlear implant. Hybrid SRW cochlear implant: Subjects will be implanted with the Hybrid SRW
Ear and labyrinth disorders
Sudden hearing threshold shift resulting in profound hearing loss
16.7%
1/6 • Number of events 1 • 1 year
Ear and labyrinth disorders
Significant decrease in hearing thresholds (20-35dB)
16.7%
1/6 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders
Skin Flap soreness
16.7%
1/6 • Number of events 1 • 1 year
Product Issues
Open circuit electrodes
16.7%
1/6 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders
bronchitis
16.7%
1/6 • Number of events 1 • 1 year
Ear and labyrinth disorders
Increased tinnitus
16.7%
1/6 • Number of events 1 • 1 year
Ear and labyrinth disorders
external otitis
16.7%
1/6 • Number of events 1 • 1 year

Additional Information

PRS Specialist, Clinical Affairs

Cochlear Limited

Phone: +612 9428 6555

Results disclosure agreements

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