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Status unknownNCT01933386Updated Oct 29, 2013

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")

A Phase 4 interventional study of SoundBite in Single Sided Deafness, sponsored by Sonitus Medical Inc. Status unknown at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-10-29.

Sponsored by Sonitus Medical Inc · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Single Sided Deafness

Keywords

  • Single Sided Deafness
  • SSD
  • Unilateral hearing loss
03

In context

Deafness

609 studies on the registry are indexed under Deafness; 111 are open to participants now.

This study's planned enrollment of 15 is below the median of 40 across 411 interventional studies indexed under Deafness.

Browse Deafness studies →

Lead sponsor

Sonitus Medical Inc is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Other
    SoundBite

    SoundBite will be used for the first 30 days

    Device: SoundBite

  • Other
    Surgically Implanted BCD

    The subject's own surgically implanted bone conduction device will be used for the first 30 days.

    Device: SoundBite

Interventions

  • DeviceSoundBite

    Non-surgical removable bone conduction device via the teeth.

    Also known as: The SoundBite Hearing System

06

What researchers measure

Primary outcomes

  1. APHAB Questionnaire

    Comparison of the SoundBite™ System and surgically implanted bone conduction devices

    Time frame: 30 days

Secondary outcomes

  1. Single Sided Deafness Questionnaire

    Comparison of the SoundBite™ System and surgically implanted BCD systems.

    Time frame: 30 days

07

Study locations

3 sites
  • Arizona Ear Center
    Phoenix, Arizona 85004, United States
  • Michigan Ear Institute
    Novi, Michigan 48374, United States
  • Ear Medical Group
    San Antonio, Texas 78240, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01933386
Lead sponsor
Sonitus Medical Inc
Responsible party
Sponsor
First posted
Sep 2, 2013
Start date
Sep 2013
Primary completion
Feb 2014 (estimated)
Completion
Feb 2014 (estimated)
Last update
Oct 29, 2013

Study contacts

Linda Galow, M.S.
Contact
linda@sonitusmedical.com
1-650-581-5094
Charles Syms, MD
principal investigator · Ear Medical Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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