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SoundBite Hearing System 24 Month Multi Site Patient Use Study

NCT01807559 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2013-05-03

No results posted yet for this study

Summary

The objective of this multi-site observational study is to further assess the long-term patient use of the Sonitus SoundBite Hearing System. Information can be gained by assessing benefit for the subjects that were enrolled in the SoundBite Hearing System Long Term Multi Site Study (Protocol CLN006) for an additional 12 months.

Conditions

  • Single Sided Deafness
  • Conductive Hearing Loss

Interventions

DEVICE

SoundBite Hearing System

The Sonitus Medical SoundBite Hearing System prosthetic device is a bone conduction device that has been FDA cleared for the treatment of single-sided deafness (SSD) and conductive hearing loss (CHL). The Sonitus Medical SoundBite Hearing System consists of an In-the-Mouth (ITM) component, an external microphone component worn behind the ear (BTE), a calibration interface cable and PC-controlled software for subject calibration. A charger is also provided to charge the ITM and the BTE. The objective of this study is multi-site observational study is to asses the long-term patient use of the Sonitus Medical SoundBite Hearing System.

Sponsors & Collaborators

  • Sonitus Medical Inc

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01807559 on ClinicalTrials.gov