Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")

October 25, 2013 updated by: Sonitus Medical Inc
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Arizona Ear Center
        • Contact:
        • Principal Investigator:
          • Mark Syms, MD
    • Michigan
    • Texas
      • San Antonio, Texas, United States, 78240
        • Ear Medical Group
        • Principal Investigator:
          • Charles Syms, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be current users of a surgically implanted digitally programmable surgically implanted bone conduction device
  • Must be >18, <80 years old
  • Must be fluent in English, as determined by the PI
  • Must have diagnosis of SSD, time since onset (≥3 months)
  • Must have at least two contiguous molar or premolar teeth with no untreated tooth decay. Patients with tooth decay present are to first have restorations before being fitted for SoundBite
  • Healthy attachment to those teeth with tooth pockets limited to no more than 5mm

Exclusion Criteria:

  • Subjects with known hypersensitivity to any of the components including allergies to polymers.
  • Subjects that are unable to use their hands such as quadriplegics or others that are unable to comply with the warnings in the product's labeling.
  • Subjects with known or active secondary medical conditions associated with variable sensorineural hearing loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: SoundBite
SoundBite will be used for the first 30 days
Device: SoundBite
Non-surgical removable bone conduction device via the teeth.
Other Names:
  • The SoundBite Hearing System
Other: Surgically Implanted BCD
The subject's own surgically implanted bone conduction device will be used for the first 30 days.
Device: SoundBite
Non-surgical removable bone conduction device via the teeth.
Other Names:
  • The SoundBite Hearing System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
APHAB Questionnaire
Time Frame: 30 days
Comparison of the SoundBite™ System and surgically implanted bone conduction devices
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single Sided Deafness Questionnaire
Time Frame: 30 days
Comparison of the SoundBite™ System and surgically implanted BCD systems.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonitus Medical Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 25, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Single Sided Deafness

Clinical Trials on SoundBite

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe