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Trial Outcomes & Findings for Cochlear Implantation for Treatment of Single-sided Deafness (NCT NCT02532972)

NCT ID: NCT02532972

Last Updated: 2020-05-05

Results Overview

Sound field thresholds following cochlear implantation via pure-tone threshold audiometry. Measured in dB HL (decibels hearing level) where a lower number means more sensitive hearing and a higher number means less sensitive hearing.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

3, 6 and 12 months post-operatively

Results posted on

2020-05-05

Participant Flow

Participant milestones

Participant milestones
Measure
Cochlear Implant Surgery
All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array Med-el MAESTRO Cochlear Implant with Flex 28 electrode array: Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.
Overall Study
STARTED
11
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Cochlear Implant Surgery
All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array Med-el MAESTRO Cochlear Implant with Flex 28 electrode array: Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.
Overall Study
Withdrawal by Subject
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cochlear Implant Surgery
n=11 Participants
All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array. Intervention consists of Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.
Age, Categorical
<=18 years
0 Participants
n=11 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=11 Participants
Age, Categorical
>=65 years
4 Participants
n=11 Participants
Age, Continuous
54 years
n=11 Participants
Sex: Female, Male
Female
8 Participants
n=11 Participants
Sex: Female, Male
Male
3 Participants
n=11 Participants
Region of Enrollment
United States
11 Participants
n=11 Participants
Sound detection via pure-tone air conduction threshold audiometry
Better Ear
13.1 dB
n=11 Participants
Sound detection via pure-tone air conduction threshold audiometry
Worse Ear
96.25 dB
n=11 Participants

PRIMARY outcome

Timeframe: 3, 6 and 12 months post-operatively

Population: 11 participants had surgery, but one subject opted out of additional follow-up after the 6 month visit one subject did not return for his one year followup visit following activation. As such,12 month time points only have 9 participants' data analyzed.

Sound field thresholds following cochlear implantation via pure-tone threshold audiometry. Measured in dB HL (decibels hearing level) where a lower number means more sensitive hearing and a higher number means less sensitive hearing.

Outcome measures

Outcome measures
Measure
Cochlear Implant Surgery
n=11 Participants
All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array Med-el MAESTRO Cochlear Implant with Flex 28 electrode array: Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.
Sound Detection Via Pure-tone Threshold Audiometry (PTA)
3 months post-operative
42.36 dB HL
Interval 31.25 to 47.5
Sound Detection Via Pure-tone Threshold Audiometry (PTA)
6 months post-operative
45.13 dB HL
Interval 33.75 to 66.25
Sound Detection Via Pure-tone Threshold Audiometry (PTA)
12 months post-operative
39.58 dB HL
Interval 35.0 to 46.25

PRIMARY outcome

Timeframe: Preop, 1-4 weeks, and 3, 6, and 12 months post-operatively

Population: 11 participants had surgery, but one subject opted out of additional follow-up after the 6 month visit one subject did not return for his one year followup visit following activation. As such,12 month time points only have 9 participants' data analyzed.

Ability to recognize words and sentences read by the tester from a set list at a loudness of 65 dB HL. The outcome is measured as a percent score of words recognized. The test takes place in a quiet environment.

Outcome measures

Outcome measures
Measure
Cochlear Implant Surgery
n=11 Participants
All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array Med-el MAESTRO Cochlear Implant with Flex 28 electrode array: Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.
Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
Pre-operative
4 percentage of words recognized
Interval 0.0 to 26.0
Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
1-4 weeks post-surgery
16 percentage of words recognized
Interval 0.0 to 34.0
Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
3 months post-surgery
42 percentage of words recognized
Interval 10.0 to 64.0
Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
6 months post-surgery
40 percentage of words recognized
Interval 4.0 to 72.0
Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
12 months post-surgery
46 percentage of words recognized
Interval 8.0 to 72.0

SECONDARY outcome

Timeframe: Preop and 12 months post-operatively

Population: 11 participants had surgery, pre and postoperative 12 month time points have 5 participants with available Tinnitus Handicap Index (THI) data 1/11 - did not have THI data available preoperatively

Tinnitus severity rated by the Tinnitus Handicap Index (THI). The THI score of 0-16 means "no or slight handicap", 18 to 36 indicates "mild", 38 to 56 indicates "moderate", 58 to 76 indicates "severe", and a score of 78-100 is classified as "catastrophic handicap"

Outcome measures

Outcome measures
Measure
Cochlear Implant Surgery
n=11 Participants
All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array Med-el MAESTRO Cochlear Implant with Flex 28 electrode array: Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.
Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI)
Pre-operative
56.2 score on a scale
Interval 6.0 to 96.0
Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI)
12 months post-surgery
6.8 score on a scale
Interval 2.0 to 14.0

Adverse Events

Cochlear Implant Surgery

Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Cochlear Implant Surgery
n=11 participants at risk
Med-El MAESTRO Cochlear Implant with Flex 28 electrode array
Respiratory, thoracic and mediastinal disorders
pneumonia
9.1%
1/11 • Number of events 1 • 1 year following surgery
Musculoskeletal and connective tissue disorders
hip replacement
9.1%
1/11 • Number of events 1 • 1 year following surgery

Other adverse events

Other adverse events
Measure
Cochlear Implant Surgery
n=11 participants at risk
Med-El MAESTRO Cochlear Implant with Flex 28 electrode array
Skin and subcutaneous tissue disorders
dermatitis (eyelid)
9.1%
1/11 • Number of events 1 • 1 year following surgery
Skin and subcutaneous tissue disorders
postauricular irritation
9.1%
1/11 • Number of events 2 • 1 year following surgery
Ear and labyrinth disorders
otitis media
9.1%
1/11 • Number of events 1 • 1 year following surgery
Skin and subcutaneous tissue disorders
incision tenderness/irritation
27.3%
3/11 • Number of events 4 • 1 year following surgery
Ear and labyrinth disorders
tinnitus
18.2%
2/11 • Number of events 2 • 1 year following surgery
Ear and labyrinth disorders
vertigo
9.1%
1/11 • Number of events 1 • 1 year following surgery
Gastrointestinal disorders
nausea and vomiting
9.1%
1/11 • Number of events 2 • 1 year following surgery
General disorders
taste disturbance
27.3%
3/11 • Number of events 4 • 1 year following surgery
Ear and labyrinth disorders
eardrum perforation
9.1%
1/11 • Number of events 1 • 1 year following surgery
Blood and lymphatic system disorders
bleeding at surgical site
9.1%
1/11 • Number of events 1 • 1 year following surgery
Product Issues
magnet retention issues requiring stronger magnet
9.1%
1/11 • Number of events 1 • 1 year following surgery
General disorders
oral dryness
9.1%
1/11 • Number of events 1 • 1 year following surgery
Ear and labyrinth disorders
hyperacusis in non-implanted ear
9.1%
1/11 • Number of events 1 • 1 year following surgery
Ear and labyrinth disorders
general otalgia and otorrhea, intermittent
9.1%
1/11 • Number of events 1 • 1 year following surgery

Additional Information

Dr. Daniel Lee

Massachusetts Eye & Ear Infirmary

Phone: 6175736981

Results disclosure agreements

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