CompletedNot Applicable

Esteem New Subject Enrollment Post Approval Study

United States117 participantsStarted 2010-08

Plain-language summary

The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject is ≥ 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 in the ear to be implanted defined by pure tone average air-conduction threshold level.
. 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 SRT + 40 decibels (dB) or at maximum tolerable presentation level.
. Subject is a current user of a properly functioning and appropriately fit hearing aid for at least one (1) month in the ear to be implanted.
. Subject has normally functioning eustachian tube
. Subject has normal tympanic membrane

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Speech Reception Threshold (SRT)

Timeframe: Change in SRT from Baseline Aided to 10-month post-activation with Esteem

Change in Word Recognition Score (WRS)

Timeframe: Change in WRS from Baseline Aided to 10-month post-activation with Esteem

Incidence of SADEs, Device Failures, & Replacements

Timeframe: Incidence at 10-month post-activation

Incidence of Facial Pareses/Paralysis

Timeframe: Incidence at one month post-op

Change in Bone Conduction Threshold (BCT) at 500 Hz

Timeframe: Change in BCT from Baseline to 10-month post-activation

Change in Bone Conduction Threshold (BCT) at 1000 Hz

Timeframe: Change in BCT from Baseline to 10-month post-activation

Change in Bone Conduction Threshold (BCT) at 2000 Hz

Timeframe: Change in BCT from Baseline to 10-month post-activation

Trial details

NCT IDNCT02689349

SponsorEnvoy Medical Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09

Results submitted2022-04-04

View on ClinicalTrials.gov More Sensorineural Hearing Loss trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject is ≥ 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 in the ear to be implanted defined by pure tone average air-conduction threshold level.
. 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 SRT + 40 decibels (dB) or at maximum tolerable presentation level.
. Subject is a current user of a properly functioning and appropriately fit hearing aid for at least one (1) month in the ear to be implanted.
. Subject has normally functioning eustachian tube
. Subject has normal tympanic membrane

Exclusion criteria

. 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

What they're measuring

Change in Speech Reception Threshold (SRT)

Timeframe: Change in SRT from Baseline Aided to 10-month post-activation with Esteem

Change in Word Recognition Score (WRS)

Timeframe: Change in WRS from Baseline Aided to 10-month post-activation with Esteem

Incidence of SADEs, Device Failures, & Replacements

Timeframe: Incidence at 10-month post-activation

Incidence of Facial Pareses/Paralysis

Timeframe: Incidence at one month post-op

Change in Bone Conduction Threshold (BCT) at 500 Hz

Timeframe: Change in BCT from Baseline to 10-month post-activation

Change in Bone Conduction Threshold (BCT) at 1000 Hz

Timeframe: Change in BCT from Baseline to 10-month post-activation

Change in Bone Conduction Threshold (BCT) at 2000 Hz

Timeframe: Change in BCT from Baseline to 10-month post-activation