Title: Esteem® Totally Implantable Hearing System Clinical Trial~Purpose: To evaluate the safety and efficacy of the Esteem® Totally Implantable Hearing System (hereafter called the Esteem® System) in subjects suffering from mild to severe hearing loss.~Trial Design: This pivotal trial is designed as a prospective, multi-center, non-randomized, clinical trial to evaluate the safety and efficacy of the Esteem® System. For this trial the subject will act as his or her own control.~This trial has been designed to meet the United States' regulatory requirements.~Enrollment Size: It is currently estimated that 50-60 subjects will be enrolled in this trial.~Subject Population: Adult subjects who have mild to severe sensorineural hearing loss, have a healthy middle ear, have a speech discrimination score of equal to or better than 40%, and have previously worn a hearing aid for a minimum of 3 months with an average daily use rate of at least 4 hours are eligible for inclusion in the trial. See detailed inclusion/exclusion criteria for specifics.~Primary Objectives:~To demonstrate that the Esteem® System improves the speech threshold of sensitivity for hearing and identifying speech signals as well as or better than the pre-implant hearing aid (aided condition).~Endpoint: Comparison of the speech reception threshold (SRT) using the Esteem® System (4 months post activation) as compared to the pre-implant aided condition.~To demonstrate that the Esteem® System at the 4 months post- activation visit is as effective as or better than the hearing aid for improving speech discrimination (intelligibility) as shown by the word recognition score at 50 dB.~Endpoint: Comparison of the word recognition score using the Esteem® at 4 months post-activation compared to the pre-implant aided condition.~To determine the incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements.~Endpoint: The analysis of the incidence of SADEs and device failures and replacements at each follow-up.~To demonstrate that the subjects' cochlear function remains unchanged with the Esteem® System as shown by comparison of the subjects' pre-implant baseline bone conduction threshold versus the subjects' 4 month post-activation visit bone conduction threshold.~Endpoint: Comparison of bone conduction threshold (BC) using forehead placement at 4 months post activation compared to the pre-implant BC threshold.~Secondary Objectives:~To demonstrate that the Esteem® System at the 4 months post activation visit improves the 3-frequency (500, 1000, and 2000 Hz) pure tone average (PTA) when compared to the baseline unaided condition.~To demonstrate that the Esteem® System at the 4 months post-activation visit is as effective as or better than the hearing aid for improving speech discrimination (intelligibility) as shown by the QuickSIN (speech in noise) test results.~To show that the Esteem® System improves Quality-of-Life when compared to the baseline aided condition as shown by APHAB results.~To gather subject feedback and comments on the use of the Esteem® System relative to the pre-implant hearing aid (aided condition) as shown by the Esteem® Questionnaire.
To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from mild to severe hearing loss.