Trial Outcomes & Findings for Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness (NCT NCT00977314)

Results Overview

The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included: Comprehensive Medical evaluation at Enrollment and at Termination Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed Comprehensive Audiological evaluation at Enrollment and Termination.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

30 days

Results posted on

2014-10-17

Participant Flow

Recruitment/Enrollment Phase(September 2009-November 2009) Location: Medical Clinics Meant to assess the subjects' ability to be enrolled in the trial, included Medical, Audiological and Dental evaluations.

Phase 1: Enrollment: Assesses the subjects' ability to be enrolled in the trial. It included medical, audiological, and dental evaluations and device fit to ensure comfort during the duration of the trial.

Participant milestones

Participant milestones
Measure	Analyzed Group 30 subjects were enrolled in the analyzed group with only 24 subjects expected to complete it. With an approximated 20% subject dropout rate anticipated. The total number of subjects that completed the study was 28 of 30 enrolled in the analyzed group.	Pilot Group Per the protocol, the first five (5) subjects were enrolled in the "pilot group" of the study to work out the process flow and training of the centers and participants.
Overall Study STARTED	30	5
Overall Study COMPLETED	28	5
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Analyzed Group 30 subjects were enrolled in the analyzed group with only 24 subjects expected to complete it. With an approximated 20% subject dropout rate anticipated. The total number of subjects that completed the study was 28 of 30 enrolled in the analyzed group.	Pilot Group Per the protocol, the first five (5) subjects were enrolled in the "pilot group" of the study to work out the process flow and training of the centers and participants.
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	1	0

Baseline Characteristics

Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Analyzed Group n=30 Participants A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it.	Pilot Group n=5 Participants A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it.	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	5 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	46.6 years STANDARD_DEVIATION 13 • n=5 Participants	45.4 years STANDARD_DEVIATION 8.1 • n=7 Participants	46.5 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	2 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	5 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included: Comprehensive Medical evaluation at Enrollment and at Termination Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed Comprehensive Audiological evaluation at Enrollment and Termination.

Outcome measures

Outcome measures
Measure	Medical, Dental, Audiological Safety 30 Days n=28 Participants The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included: * Comprehensive Medical evaluation at Enrollment and at Termination * Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed * Comprehensive Audiological evaluation at Enrollment and Termination. No Medical, Dental or Audiological adverse events.
Incidence of Device- and Procedure-related Adverse Events at 30 Days	0 participants

PRIMARY outcome

Timeframe: Day 1, Day 30

The primary efficacy outcome was a measure of the ability to understand speech in noise while wearing the device compared with not wearing the device. The Hearing in Noise Test (HINT) was utilized for this measure as it is the most widely used test for SSD devices. An improvement in HINT score is indicated as a negative (-) dB value change. A more negative (-dB) value indicates an improvement in understanding speech in noise. An improvement in a HINT score of -1 dB is equivalent to a 10% improvement in the ability to understand speech in noise and is likely of clinical benefit. The scores are calculated as HINT Advantage (aided compared with unaided) which depict the differences of using a device as compared to not wearing a device.

Outcome measures

Outcome measures
Measure	Medical, Dental, Audiological Safety 30 Days n=28 Participants The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included: * Comprehensive Medical evaluation at Enrollment and at Termination * Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed * Comprehensive Audiological evaluation at Enrollment and Termination. No Medical, Dental or Audiological adverse events.
Efficacy: Ability to Understand Speech in Noise	-2.5 dB Standard Deviation 1

SECONDARY outcome

Timeframe: 30 days

The measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB), a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. A software program is utilized to score the APHAB and results are compared a different time points. The APHAB is well characterized and broadly used as a quantifiable measurement of device benefit. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment)

Outcome measures

Outcome measures
Measure	Medical, Dental, Audiological Safety 30 Days n=28 Participants The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included: * Comprehensive Medical evaluation at Enrollment and at Termination * Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed * Comprehensive Audiological evaluation at Enrollment and Termination. No Medical, Dental or Audiological adverse events.
Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB).	18.80 Global Benefit Score Standard Deviation 13.36

Adverse Events

Incidence of Device- and Procedure-related Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trials Manager

Sonitus Medical, Inc.

Phone: 8668162076

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60