Trial Outcomes & Findings for Safety and Efficacy of the Vibrant Soundbridge (VSB) for Mixed and Conductive Hearing Losses (NCT NCT00748540)

NCT ID: NCT00748540

Last Updated: 2019-09-25

Results Overview

Percent correct on words in quiet at the preoperative interval compared to 6 month post operative interval.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 6 months post initial activation
• Results posted on: 2019-09-25

Participant Flow

Participant milestones

Measure	Implanted Implanted with Vibrant Soundbridge Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation
Overall Study STARTED	50
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Implanted Implanted with Vibrant Soundbridge Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation
Overall Study Physician Decision	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Implanted n=50 Participants Implanted with Vibrant Soundbridge Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation
Age, Categorical <=18 years	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=50 Participants
Age, Categorical >=65 years	3 Participants n=50 Participants
Age, Continuous	46 years n=50 Participants
Sex: Female, Male Female	29 Participants n=50 Participants
Sex: Female, Male Male	21 Participants n=50 Participants
Region of Enrollment United States	50 Participants n=50 Participants

PRIMARY outcome

Timeframe: 6 months post initial activation

Percent correct on words in quiet at the preoperative interval compared to 6 month post operative interval.

Outcome measures

Measure	Implanted n=49 Participants Implanted with Vibrant Soundbridge Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation
Speech Perception in Quiet (Monosyllables) in Patients Implanted With Vibrant Soundbridge	94.12 percentage of words correct Standard Deviation 6.25

SECONDARY outcome

Timeframe: 6 months post initial activation

Auditory thresholds in the soundfield at the preoperative interval compared to the 6 month postoperative interval.

Outcome measures

Measure	Implanted n=49 Participants Implanted with Vibrant Soundbridge Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation
Functional Gain Compared to Preoperative Unaided Condition in Patients Implanted With Vibrant Soundbridge. Worsened	0 Participants
Functional Gain Compared to Preoperative Unaided Condition in Patients Implanted With Vibrant Soundbridge. Improved	44 Participants
Functional Gain Compared to Preoperative Unaided Condition in Patients Implanted With Vibrant Soundbridge. No change	5 Participants

SECONDARY outcome

Timeframe: 6 months post initial activation

Population: 3 subjects did not completed this testing due to limitations of the equipment used.

Signal to Noise Ratio for sentences at the preoperative interval compared to the 6 month interval.

Outcome measures

Measure	Implanted n=46 Participants Implanted with Vibrant Soundbridge Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation
Speech Perception in Noise (HINT Sentences) in Patients Implanted With Vibrant Soundbridge.	0.24 Signal to Noise Ratio Standard Deviation 3.97

SECONDARY outcome

Timeframe: 10 months post initial activation

Unaided hearing thresholds measured at the 10 month interval compared to the preoperative interval in order to assess any changes

Outcome measures

Measure	Implanted n=50 Participants Implanted with Vibrant Soundbridge Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation
Residual Hearing in Patients Implanted With Vibrant Soundbridge Maintained residual hearing	48 Participants
Residual Hearing in Patients Implanted With Vibrant Soundbridge Decreased residual hearing	2 Participants

Adverse Events

Implanted

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Implanted n=50 participants at risk Implanted with Vibrant Soundbridge Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation
Ear and labyrinth disorders Staph infection following revision surgery	2.0% 1/50 • Number of events 1
Ear and labyrinth disorders Device removal due to tuberculosis infection	2.0% 1/50 • Number of events 1

Other adverse events

Measure	Implanted n=50 participants at risk Implanted with Vibrant Soundbridge Vibrant Soundbridge: Mixed and conductive hearing loss using round window stimulation
Ear and labyrinth disorders Conductor link exposure	10.0% 5/50 • Number of events 7
Ear and labyrinth disorders FMT off the round window	14.0% 7/50 • Number of events 7
Ear and labyrinth disorders Electromagnetic interference	10.0% 5/50 • Number of events 6
Ear and labyrinth disorders Defective audio processor	8.0% 4/50 • Number of events 4
Ear and labyrinth disorders Recurrence of cholesteoma	6.0% 3/50 • Number of events 4

Additional Information

Allison Racey, AuD

MED-EL Corporation

Phone: 888-633-3524

Email: allison.racey@medel.com

Results disclosure agreements

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

Restriction type: LTE60