Trial Outcomes & Findings for BONEBRIDGE Bone Conduction Implant in Adults (NCT NCT03859648)

Results Overview

Adverse events will be collected and reported throughout the duration of the study.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

Up to three (3 months) post activation

Results posted on

2024-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	BONEBRIDGE Subjects implanted with the transcutaneous bone conduction implant
Overall Study STARTED	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	BONEBRIDGE Subjects implanted with the transcutaneous bone conduction implant
Overall Study Lost to Follow-up	1
Overall Study Adverse Event	1

Baseline Characteristics

This information was not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BONEBRIDGE n=8 Participants All subjects implanted with the transcutaneous bone conduction implant.
Age, Continuous	47 years n=8 Participants
Sex: Female, Male Female	0 Participants This information was not collected from any participant.
Sex: Female, Male Male	0 Participants This information was not collected from any participant.
Region of Enrollment Canada	5 participants n=8 Participants
Region of Enrollment United States	3 participants n=8 Participants
Duration of hearing loss	28.4 years n=8 Participants

PRIMARY outcome

Timeframe: Up to three (3 months) post activation

Population: One subject did not pursue surgery after baseline evaluation. This subject was removed from this analysis.

Adverse events will be collected and reported throughout the duration of the study.

Outcome measures

Outcome measures
Measure	BONEBRIDGE n=8 Participants All subjects implanted with the transcutaneous bone conduction implant.
Number and Proportion of Subjects Experiencing Device Related Adverse Events	1 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months post activation

Population: One subject was lost to follow up after 1 month, and one subject did not participate in postoperative intervals due to an adverse event. These subjects were removed from this analysis.

Percent improvement in AZ Bio sentence in noise scores will be compared from baseline to 3 months post activation.

Outcome measures

Outcome measures
Measure	BONEBRIDGE n=6 Participants All subjects implanted with the transcutaneous bone conduction implant.
Percentage Change in AZ Bio Sentence Score in Noise	42.2 percent improvement Interval 23.0 to 95.0

SECONDARY outcome

Timeframe: Baseline and 3 months post activation

Population: One subject was lost to follow up after 1 month, and one subject did not participate in postoperative intervals due to an adverse event. These subjects were removed from this analysis.

Percent improvement in CNC word scores will be compared from baseline to 3 months post activation.

Outcome measures

Outcome measures
Measure	BONEBRIDGE n=6 Participants All subjects implanted with the transcutaneous bone conduction implant.
Percentage Change in CNC Word Score	38.3 percent improvement Interval 23.0 to 70.0

SECONDARY outcome

Timeframe: Baseline and 3 months post activation

Population: One subject was lost to follow up after 1 month, one subject did not participate in postoperative intervals due to an adverse event, and sound field data was missing for one subject. These subjects were removed from this analysis.

The number of subjects with stable or better aided soundfield thresholds at 3 months post activation compared to baseline unaided soundfield thresholds

Outcome measures

Outcome measures
Measure	BONEBRIDGE n=5 Participants All subjects implanted with the transcutaneous bone conduction implant.
Number of Subjects With Stable or Better Soundfield Thresholds	5 Participants

SECONDARY outcome

Timeframe: Baseline and 3 months post activation

Population: One subject was lost to follow up after 1 month, and one subject did not participate in postoperative intervals due to an adverse event. These subjects were removed from this analysis.

The number of subjects with similar or better performance on the QuickSIN (Speech In Noise) task in the implanted ear compared to baseline performance

Outcome measures

Outcome measures
Measure	BONEBRIDGE n=6 Participants All subjects implanted with the transcutaneous bone conduction implant.
Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance	6 Participants

SECONDARY outcome

Timeframe: Baseline and 2 weeks post surgery

Population: One subject did not participate in postoperative intervals due to an adverse event. These subjects were removed from this analysis.

The number of subjects with stable bone conduction thresholds at the device activation interval compared to pre-operative bone conduction thresholds.

Outcome measures

Outcome measures
Measure	BONEBRIDGE n=7 Participants All subjects implanted with the transcutaneous bone conduction implant.
Number of Subjects With Stable Unaided Bone Conduction Thresholds	7 Participants

Adverse Events

BONEBRIDGE

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BONEBRIDGE n=8 participants at risk All subjects implanted with the transcutaneous bone conduction implant.
Infections and infestations Postoperative infection	12.5% 1/8 • Number of events 1 • Adverse events were collected from surgery through 3 months post-activation.

Other adverse events

Other adverse events
Measure	BONEBRIDGE n=8 participants at risk All subjects implanted with the transcutaneous bone conduction implant.
Skin and subcutaneous tissue disorders Scalp sensitivity	12.5% 1/8 • Number of events 1 • Adverse events were collected from surgery through 3 months post-activation.

Additional Information

MED-EL Corporation

Phone: 919-314-1437

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place