The Esteem® Hearing Implant Post Approval Study

Completed

Conditions studied: Hearing Loss

In brief

The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem® Hearing Implant in subjects suffering from moderate to severe hearing loss.

Key facts

Study ID

NCT02666222

Run by

Envoy Medical Corporation

People needed

51

Starts

2010-08-01

Expected to finish

2015-03-01

Last updated by the study team

2016-05-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject must meet all of the following criteria to be eligible for treatment in the trial:
• Subject is at least 18 years old
• Subject understands the nature of the procedure and has signed the Subject Informed Consent Form prior to the procedure
• Subject is willing and able to comply with specified follow-up evaluations and understands the audiological test procedures and use of the Esteem® System.
• Subject has moderate to severe sensorineural hearing loss between 500 and 4000 Hz in the ear to be implanted with pure tone air-conduction threshold levels within the limits of a Hearing Aid (HA) as follow:
• Freq (Hz) 500 1000 2000 3000 4000 Lower Level (dB HL) 30 35 35 35 35 Upper Level (dB HL) 100 100 100 100 100
• Subject's air-bone gap is no greater than 10 dB at 4 of the 5 following frequencies: 500, 1000, 2000, 3000 and 4000 Hz.
• Subject has an unaided maximum word recognition score of greater than or equal to 40% with recorded delivery using a phonetically balanced word list at Speech Reception Threshold (SRT) + 40 dB or at maximum tolerable presentation level.
• Subject is a current user of a properly functioning and appropriately fit hearing aid. This is defined as the subject has used this aid for at least four (4) hours (average) per day (in the ear to be implanted) for at least three (3) months for a new aid or one (1) month for an adjusted aid.
• Subject's hearing aid, in the ear to be implanted, shall appropriately fit optimally.
• Subject has normally functioning eustachian tube
• Subject has normal tympanic membrane
• Subject has a normal middle ear anatomy
• Subject has adequate space for Esteem® System implant determined via fine cut temporal bone CT scan
• Subject is a native speaker of the English language.
• Subject is a hearing aid user in the ear to be implanted

You may not qualify if…

• Subjects will be excluded from the trial if any one of the following criteria is met:
• Subject has a history of post-adolescent chronic middle ear infections, inner ear disorders or recurring vertigo requiring treatment, disorders such as mastoiditis, Hydrops or Meniere's syndrome or disease
• Subject has a history of external otitis or eczema for the outer ear canal and the investigator believes this will affect the Esteem® System implantation
• Subject has cholesteatoma or destructive middle ear disease
• Subject has life expectancy of less than two (2) years due to other medical conditions
• Subject has retrocochlear or central auditory disorders
• Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with the surgery or follow-up testing
• Subject has a known history of fluctuating air conduction and/or bone conduction hearing loss over a one-year period of 15 dB in either direction at 2 or more frequencies (from 500 - 4000 Hz)
• Subject has sudden hearing loss due to unknown cause
• Subject has a history of disabling tinnitus, defined as tinnitus which required treatment.
• Subject is unable to adequately perform audiological testing
• Subject has a medical condition or undergoing a treatment that may affect healing and the investigator does not believe the subject is a good candidate for the trial.
• Subject has diabetes that is not well controlled with medication or diet and the investigator does not believe in his best medical judgment that the subject would be a good candidate for the trial
• Subject is pregnant at the time of device implant
• Subject has a history of keloid formation
• Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold

Where it is running

• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Shohet Ear Associates — Newport Beach, California, United States
• Lahey Clinic, Inc. — Burlington, Massachusetts, United States
• Surgical Care Affiliates — Greensboro, North Carolina, United States
• The Ear Center of Greensboro — Greensboro, North Carolina, United States

Full record on ClinicalTrials.gov

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