The Esteem® Hearing Implant Post Approval Study

NCT02666222 | Completed Results DMC

• 1 other identifier: 0204 Post-Approval Study (PAS)
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Hearing Loss

Keywords

hearing loss; sensorineural; hearing implant

Outcome Measures

Primary Outcomes (4)

• Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT)

  ENDPOINT #1: SRT at baseline minus SRT at Year 5. Positive difference (i.e. lower value of SRT with the Esteem) indicates better outcome.

  Baseline through Year 5 of Follow Up

• Change From Baseline (Pre-implant Aided Condition) at Year 5 in Word Recognition Score (WRS) at 50 dB HL

  ENDPOINT #2: WRS at Year 5 minus WRS at baseline. Positive difference (in % correct) indicates better outcome.

  Baseline through Year 5 of Follow Up

• Incidence of Serious Adverse Device Events (SADEs) and Device Failures and Replacements at Each Follow-up.

  ENDPOINT #3: The analysis of the incidence of SADEs and device failures and replacements at each follow-up.

  SADEs, PAS phase through Year 5 of Follow Up

• Bone Conduction Stability

  ENDPOINT #5: Difference between Baseline and 5 Year Pure-Tone Average (PTA; average of 500, 1000, 2000 Hz thresholds); calculated as PTA at Year 5 minus PTA at baseline. Smaller magnitude dB difference indicates better outcome.

  Baseline through 5 Year Follow-Up

Secondary Outcomes (1)

• Improvement in Quality of Life as Reflected by Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire

  Baseline through Year 5 of Follow Up

Interventions

The Esteem Hearing Implant DEVICE

The Esteem® Hearing Implant is designed to improve hearing in subjects suffering from moderate to severe hearing loss that is sensorineural in origin. The Esteem® has been approved by FDA for the US market under Pre-Market Approval P090018 and this study fulfills the requirement for one of the Post Approval Studies.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons suffering from moderate to severe hearing loss that is sensorineural in origin

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.

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

Sponsors & Collaborators

• Envoy Medical Corporation: lead

Study Sites (5)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

Shohet Ear Associates

Newport Beach, California, 92663, United States

Location

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Surgical Care Affiliates

Greensboro, North Carolina, 27401, United States

Location

The Ear Center of Greensboro

Greensboro, North Carolina, 27401, United States

Location

Related Links

• Invisible Hearing with Esteem®

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1. Study endpoints do not account for natural progression of hearing loss over 5-year follow-up. 2. Fitting methods for pre-implant hearing aid were not strictly controlled in the protocol.

Results Point of Contact

• Title: Elizabeth Anderson, PhD
• Organization: Envoy Medical Corp.

landerson@envoymedical.com

651-361-8080

Study Officials

• Jack A Shohet, MD

  Hoag Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Elizabeth H Toh, MBBS; MD

  Lahey Clinic Medical Center

  PRINCIPAL INVESTIGATOR

• Eric M Kraus, MD, MS, FACS

  Moses H. Cone Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: January 28, 2016
• Study Start: August 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 4, 2016
• Results First Posted: May 4, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)