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

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ClinicalTrials.gov Identifier: NCT00977314
Recruitment Status : Completed
First Posted : September 15, 2009
Results First Posted : October 17, 2014
Last Update Posted : October 17, 2014
Sponsor:
Information provided by (Responsible Party):
Sonitus Medical Inc

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Unilateral Hearing Loss
Interventions Device: The Sonitus Bone Conduction Hearing System
Device: SoundBite
Device: SoundBite Hearing System
Enrollment 35
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Analyzed Group Pilot Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 30 5 [1]
Completed 28 5 [1]
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Physician Decision             1             0
[1]
First 5 subjects enrolled were pilot subjects and not included in analysis.
Arm/Group Title Analyzed Group Pilot Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 30 5 35
Hide Baseline Analysis Population Description
35 subjects were enrolled in this study.Per protocol,the first 5 subjects enrolled were the pilot phase of the study. Data obtained from the first 5 subjects were excluded from analyses.An approximated 20% subject dropout rate anticipated, 30 subjects were enrolled with 24 subjects expected complete.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 5 participants 35 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
  96.7%
5
 100.0%
34
  97.1%
>=65 years
1
   3.3%
0
   0.0%
1
   2.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 5 participants 35 participants
46.6  (13) 45.4  (8.1) 46.5  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 5 participants 35 participants
Female
15
  50.0%
3
  60.0%
18
  51.4%
Male
15
  50.0%
2
  40.0%
17
  48.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 5 participants 35 participants
30 5 35
1.Primary Outcome
Title Incidence of Device- and Procedure-related Adverse Events at 30 Days
Hide Description

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.

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical, Dental, Audiological Safety 30 Days
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
0
2.Primary Outcome
Title Efficacy: Ability to Understand Speech in Noise
Hide Description 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.
Time Frame Day 1, Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HINT (dB) Advantage
Hide Arm/Group Description:

Effectiveness was defined as “Change from Baseline” analysis of the Hearing in Noise Test (HINT), Noise on Better Side Scores between without the BCD at day one and with the BCD at day thirty.Effectiveness was determined as an improvement in the HINT score for which the device was designed, that is, the condition where noise originates on the normal hearing side and speech is presented from the front. .

An improvement in HINT score is indicated as a negative (-) dB value change. A change in the HINT score of -1 dB represents an improvement of 10% in speech intelligibility in that particular test condition. A 10% improvement in speech intelligibility in this very adverse listening condition is a noticeable benefit to the SSD subject. This amount of improvement is even more of a benefit in more realistic, less adverse listening conditions.

Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: dB
-2.5  (1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HINT (dB) Advantage
Comments The endpoint was the calculated difference between the HINT result for the unaided condition prior to the 30-day trial period (Day 1) and the HINT result using the SoundBite (aided) at the end of the 30-day trial period (Day 30).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.5
Parameter Dispersion
Type: Standard Deviation
Value: 1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB).
Hide Description 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)
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Global Benefit
Hide Arm/Group Description:
The Global Benefit APHAB at 30 days is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 30 days of therapy. The APHAB questionnaire produces an overall Global score (GBL). The benefit provided by the SoundBite System can be determined by comparing changes in the mean APHAB score. The larger the APHAB benefit score the great the benefit. A negative APHAB score represents therapy resulting in a worse outcome than no therapy.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Global Benefit Score
18.80  (13.36)
Time Frame 30 days
Adverse Event Reporting Description Incidence of device- and procedure-related adverse events at 30 days
 
Arm/Group Title Incidence of Device- and Procedure-related Adverse Events
Hide Arm/Group Description Incidence of device- and procedure-related adverse events at 30 days
All-Cause Mortality
Incidence of Device- and Procedure-related Adverse Events
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Incidence of Device- and Procedure-related Adverse Events
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Incidence of Device- and Procedure-related Adverse Events
Affected / at Risk (%)
Total   0/28 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials Manager
Organization: Sonitus Medical, Inc.
Phone: 8668162076
EMail: lily@sonitusmedical.com
Other Publications:
Layout table for additonal information
Responsible Party: Sonitus Medical Inc
ClinicalTrials.gov Identifier: NCT00977314     History of Changes
Other Study ID Numbers: CLN002
First Submitted: September 14, 2009
First Posted: September 15, 2009
Results First Submitted: June 4, 2013
Results First Posted: October 17, 2014
Last Update Posted: October 17, 2014