section_subject: "Active implantable bone conduction hearing system."
cfr_reference: "21 CFR 874.3340"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(a)Identification. An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Clinical performance testing must characterize any adverse events observed during implantation and clinical use, and must also demonstrate that the device performs as intended under anticipated conditions of use.
(2)Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i)Performance data must validate force output in a clinically relevant model.
(ii)Impact testing in a clinically relevant anatomic model must be performed.
(iii)Mechanical integrity testing must be performed.
(iv)Reliability testing consistent with expected device life must be performed.
(3)The patient-contacting components of the device must be demonstrated to be biocompatible.
(4)Performance data must demonstrate the sterility of the patient-contacting components of the device.
(5)Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6)Performance data must demonstrate the wireless compatibility, electromagnetic compatibility, and electrical safety of the device.
(7)Software verification, validation, and hazard analysis must be performed.