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")

Phase 4

• Conditions: Single Sided Deafness

• Registration Number: NCT01933386
• Lead Sponsor: Sonitus Medical Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-08-30
• Study Start: 2013-09
• Study First Posted: 2013-09-02
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-25
• Last Update Posted: 2013-10-29
• Primary Completion: 2014-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
APHAB Questionnaire	30 days	Comparison of the SoundBite™ System and surgically implanted bone conduction devices

Secondary Outcome Measures

Name	Time	Method
Single Sided Deafness Questionnaire	30 days	Comparison of the SoundBite™ System and surgically implanted BCD systems.

Trial Locations

Locations (3)

Arizona Ear Center; 🇺🇸 Phoenix, Arizona, United States

Michigan Ear Institute; 🇺🇸 Novi, Michigan, United States

Ear Medical Group; 🇺🇸 San Antonio, Texas, United States