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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sonitus Medical Inc
ClinicalTrials.gov Identifier:
NCT00977314
First received: September 14, 2009
Last updated: October 10, 2014
Last verified: October 2014
Results First Received: June 4, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Unilateral Hearing Loss
Interventions: Device: The Sonitus Bone Conduction Hearing System
Device: SoundBite
Device: SoundBite Hearing System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Analyzed Group     Pilot Group  
STARTED     30     5 [1]
COMPLETED     28     5 [1]
NOT COMPLETED     2     0  
Withdrawal by Subject                 1                 0  
Physician Decision                 1                 0  
[1] First 5 subjects enrolled were pilot subjects and not included in analysis.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Analyzed Group 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 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 Total of all reporting groups

Baseline Measures
    Analyzed Group     Pilot Group     Total  
Number of Participants  
[units: participants]
  30     5     35  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     29     5     34  
>=65 years     1     0     1  
Age  
[units: years]
Mean ± Standard Deviation
  46.6  ± 13     45.4  ± 8.1     46.5  ± 11.8  
Gender  
[units: participants]
     
Female     15     3     18  
Male     15     2     17  
Region of Enrollment  
[units: participants]
     
United States     30     5     35  



  Outcome Measures
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1.  Primary:   Incidence of Device- and Procedure-related Adverse Events at 30 Days   [ Time Frame: 30 days ]

2.  Primary:   Efficacy: Ability to Understand Speech in Noise   [ Time Frame: Day 1, Day 30 ]

3.  Secondary:   Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB).   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Trials Manager
Organization: Sonitus Medical, Inc.
phone: 8668162076
e-mail: lily@sonitusmedical.com


Publications of Results:
Other Publications:


Responsible Party: Sonitus Medical Inc
ClinicalTrials.gov Identifier: NCT00977314     History of Changes
Other Study ID Numbers: CLN002
Study First Received: September 14, 2009
Results First Received: June 4, 2013
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration