In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
The Post-Approval Study is similar to the PMA pivotal clinical trial, which was 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 acts as his or her own control.
Study Population Description
Subjects 18 years of age and older who have moderate to severe sensorineural hearing loss
(HL) defined by PTA, have a healthy middle ear, have an unaided speech discrimination score of equal to or better than 40%, and have previously worn a hearing aid for a minimum of 30 days are eligible for inclusion in the Post Approval Study.
Subject must meet all of the following criteria to be eligible for treatment in the trial:
a) Subject is ≥ 18 years old
b) Subject understands the nature of the procedure and has signed the Subject Informed Consent Form prior to the procedure
c) Subject is willing and able to comply with specified follow-up evaluations and understands the audiological test procedures and use of the Esteem® System.
d) Subject has moderate to severe sensorineural hearing loss in the ear to be implanted defined by pure tone average air-conduction threshold level.
e) 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 dB or at maximum tolerable presentation level.
f) 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.
g) Subject has normally functioning eustachian tube
h) Subject has normal tympanic membrane
i) Subject has a normal middle ear anatomy
j) Subject has adequate space for Esteem® System implant determined via fine cut temporal bone CT scan
k) Subject is a native speaker of the English language.
Subjects will be excluded from the trial if any one of the following criteria is met:
a. 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
b. Subject has a history of otitis externa or eczema for the outer ear canal and the investigator believes this will affect the Esteem® System implantation
c. Subject has cholesteatoma or destructive middle ear disease
d. Subject has life expectancy of < two (2) years due to other medical conditions
e. Subject has retrocochlear or central auditory disorders
f. 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
g. 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)
h. Subject has sudden hearing loss due to unknown cause
i. Subject has a history of disabling tinnitus, defined as tinnitus which required treatment.
j. Subject is unable to adequately perform audiological testing
k. 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.
l. 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
m. Subject is pregnant at the time of device implant
n. Subject has a history of keloid formation
o. Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold
A minimum total of 120 new subjects will be enrolled and implanted in this study
by newly trained surgeons at 5 to 10 investigational sites on a consecutive consenting basis.
For the effectiveness objectives, based upon the following analysis and pre-market clinical data, a sample size of 45 new subjects meets the guidelines for statistical power. For the facial pareses/paralysis objective with an end point of 1 month, a sample size of 109 subjects is required as shown below. As a result, the sample size enrollment of 120 subjects is adequate to assure minimums that account for attrition through 5 year follow-up for effectiveness and 1 month follow-up for facial pareses/paralysis.
1) 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 as compared to the pre-implant aided condition.
2) To demonstrate that the Esteem® System is as effective as or better than the hearing aid for improving speech discrimination (intelligibility).
3) To determine the incidence of Serious Adverse Device Effects. Endpoint: The analysis of the incidence of SADEs and device failures and replacements at each follow-up.
4) To demonstrate that the incidence of facial pareses/paralysis is no greater than the 7% incidence experienced in the PMA clinical trial.
Endpoint: The analysis of the incidence of facial pareses/paralysis at 1 month follow-up.
Followup Visits and Length of Followup
The goal will be to monitor the subjects through their five (5) year follow-up.
be evaluated at screening, implantation, activation, 1 month, 4 months, 10 months post-implant and yearly thereafter.