Otologics
Protocol Number: D104584
Therapeutic Area: ENT
Summary:
To evaluate the safety and effectiveness of the Fully Implantable MET Ossicular Stimulator, a fully implantable hearing device designed to address the amplification needs of adults (18 years of age or older) with moderate to severe sensorineural hearing loss, through mechanical stimulation of the ossicles
Inclusion Criteria:
- Bilateral moderate to severe sensorineural hearing loss within the candidacy audiogram range
- Unaided NU-6 or W-22 score > 40% at 80 dB HL or 40 dB SL in the ear to be implanted
- Post linguistic onset of hearing loss
- Non-fluctuating/stable hearing loss
- No disproportion changes in speech recognition performance
- Normal middle ear anatomy
- Has used appropriate and optimally fitted hearing aids (either binaurally or monaurally in the ear to be implanted) for at least 3 months in the past year.
- English speaking.
Exclusion Criteria:
- Vestibular disorder, including Meniere’s Syndrome
- Osteodegenerative disorder, including Paget’s disease
- Middle ear pathology, including history of recurrent otitis media
- Retrocochlear hearing loss
*Additional Eligibility Criteria Exist*
Sponsor: 
Center Name: Mercy Research Institute at Mercy Hospital
Contact Information: Mercy Research Institute Clinical Trial Coordinators
Address: 3659 South Miami Avenue, Suite 3001, Miami, Florida 33133
Phone: (305) 854-4400, ext. 2312
Fax: (305) 285-2791
E-mail: mcontreras@mercymiami.org