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Long Term Safety of the Sonitus SoundBite System

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ClinicalTrials.gov Identifier: NCT01108406
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : October 10, 2014
Last Update Posted : October 20, 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
Conditions Hearing Loss
Unilateral Hearing Loss
Total Unilateral Deafness
Interventions Device: Sonitus SoundBite System
Device: SoundBite Hearing System
Enrollment 22
Recruitment Details Recruitment occurred in April 2010. Subjects were informed about the potential for participation via IRB approved flyers or by indicating interest on consent forms from other studies.
Pre-assignment Details  
Arm/Group Title Sonitus SoundBite System
Hide Arm/Group Description Long Term Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
Period Title: Overall Study
Started 22
Completed 22
Not Completed 0
Arm/Group Title Long Term Safety
Hide Arm/Group Description Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
  95.5%
>=65 years
1
   4.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
44.41  (11.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
11
  50.0%
Male
11
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title Long Term Safety
Hide Description The safety outcomes were defined as no changes in medical, auditory, or dental status and no device or procedure related adverse events during the study period. Safety was evaluated by conducting a Comprehensive Medical evaluation at Enrollment and at study termination; Comprehensive Dental evaluation at Enrollment and at 3 and 6 months, with interim dental checks in between if necessary and Comprehensive Audiological evaluation at Enrollment and at 6 months.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Number of Participants Experiencing no Adverse Events
Hide Arm/Group Description:
Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure. Dental measurements included periodontal measurements (bone loss, oral health, bleeding index, calculus, peridontal probing) at baseline compared to 6 months. Audiological included hearing evaluation and aided thresholds baseline compared to 6 months and medical compared medical and ear health baseline compared to 6 months.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
22
2.Secondary Outcome
Title Measurement of Device Benefit With the 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. Software is used to score the APHAB and results are compared from the different timepoints. The APHAB is well characterized and broadly used as a quantifiable measurement. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment).
Time Frame 3 months and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Global Benefit APHAB Score Aided 3 Months Global Benefit APHAB Score Aided 6 Months
Hide Arm/Group Description:
The Global Benefit APHAB at 3 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 3 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
The Global Benefit APHAB at 6 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 6 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Global Benefit Score
21.3  (16.9) 23.1  (16.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Long Term Safety
Hide Arm/Group Description Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
All-Cause Mortality
Long Term Safety
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Long Term Safety
Affected / at Risk (%)
Total   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Long Term Safety
Affected / at Risk (%)
Total   0/22 (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
Name/Title: Lily Woodby, AuD
Organization: Sonitus Medical, Inc.
Phone: 8668162076
Other Publications:
Responsible Party: Sonitus Medical Inc
ClinicalTrials.gov Identifier: NCT01108406     History of Changes
Other Study ID Numbers: CLN005.00
First Submitted: April 15, 2010
First Posted: April 22, 2010
Results First Submitted: June 1, 2013
Results First Posted: October 10, 2014
Last Update Posted: October 20, 2014