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Long Term Safety of the Sonitus SoundBite System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sonitus Medical Inc
ClinicalTrials.gov Identifier:
NCT01108406
First received: April 15, 2010
Last updated: October 10, 2014
Last verified: October 2014
Results First Received: June 1, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hearing Loss
Unilateral Hearing Loss
Total Unilateral Deafness
Interventions: Device: Sonitus SoundBite System
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 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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sonitus SoundBite System Long Term Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.

Participant Flow:   Overall Study
    Sonitus SoundBite System  
STARTED     22  
COMPLETED     22  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
Long Term Safety Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.

Baseline Measures
    Long Term Safety  
Number of Participants  
[units: participants]
  22  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     21  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  44.41  ± 11.54  
Gender  
[units: participants]
 
Female     11  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     22  



  Outcome Measures
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1.  Primary:   Long Term Safety   [ Time Frame: 6 months ]

2.  Secondary:   Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB)   [ Time Frame: 3 months and 6 months ]


  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
No text entered.


  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: Lily Woodby, AuD
Organization: Sonitus Medical, Inc.
phone: 8668162076
e-mail: lily@sonitusmedical.com


Publications of Results:
Other Publications:


Responsible Party: Sonitus Medical Inc
ClinicalTrials.gov Identifier: NCT01108406     History of Changes
Other Study ID Numbers: CLN005.00
Study First Received: April 15, 2010
Results First Received: June 1, 2013
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration