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
• Interventions: Device: SoundBite

• 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

Arm && Interventions

Group	Intervention	Description
SoundBite	SoundBite	SoundBite will be used for the first 30 days
Surgically Implanted BCD	SoundBite	The subject's own surgically implanted bone conduction device will be used for the first 30 days.

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)

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

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

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