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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")

NCT01933386 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-10-29

No results posted yet for this study

Summary

The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.

Conditions

  • Single Sided Deafness

Interventions

DEVICE

SoundBite

Non-surgical removable bone conduction device via the teeth.

Sponsors & Collaborators

  • Sonitus Medical Inc

    lead INDUSTRY

Principal Investigators

  • Charles Syms, MD · Ear Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-02-28
Completion
2014-02-28

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 NCT01933386 on ClinicalTrials.gov