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")

S

Sonitus Medical

Status and phase

Unknown
Phase 4

Conditions

Single Sided Deafness

Treatments

Device: SoundBite

Study type

Interventional

Funder types

Industry

Identifiers

NCT01933386
CLN008

Details and patient eligibility

About

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

Enrollment

15 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

15 participants in 2 patient groups

SoundBite
Other group
Description:
SoundBite will be used for the first 30 days
Treatment:
Device: SoundBite
Surgically Implanted BCD
Other group
Description:
The subject's own surgically implanted bone conduction device will be used for the first 30 days.
Treatment:
Device: SoundBite

Trial contacts and locations

0

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Central trial contact

Linda Galow, M.S.

Data sourced from clinicaltrials.gov

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