Last synced on 25 November 2022 at 11:04 pm

Active Implantable Bone Conduction Hearing System

Page Type
Product Code
Definition
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.
Physical State
The device has an implantable component and an external audio processor component. Both components are made of different metals, alloys and/or plastic materials.
Technical Method
Bone conduction implant that is surgically attached to the mastoid bone and an external audio processor that is held in place on the patient's scalp by magnetic attraction between the implant and the audio processor. The audio processor contains microphones that pick up sound and speech from the environment and convert them into a signal that can be transmitted across the skin to the implant. The signal transmitted by the Audio Processor is converted into controlled vibrations of the mastoid bone by the implant, which are perceived as sound.
Target Area
The patient's hearing will be affected by this device. Since it is an implant on the patient's skull behind the ear, the areas of the skull and skin over the implant will be affected, including the ear.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.3340
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.3340 Active implantable bone conduction hearing system

§ 874.3340 Active implantable bone conduction hearing system.

(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.

(8) Labeling must include:

(i) A summary of clinical testing conducted with the device that includes a summary of device-related complications and adverse events;

(ii) Instructions for use;

(iii) A surgical guide for implantation, which includes instructions for imaging to assess bone dimensions;

(iv) A shelf life, for device components provided sterile;

(v) A patient identification card; and

(vi) A patient user manual.

[83 FR 54009, Oct. 26, 2018]

Active Implantable Bone Conduction Hearing System

Page Type
Product Code
Definition
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.
Physical State
The device has an implantable component and an external audio processor component. Both components are made of different metals, alloys and/or plastic materials.
Technical Method
Bone conduction implant that is surgically attached to the mastoid bone and an external audio processor that is held in place on the patient's scalp by magnetic attraction between the implant and the audio processor. The audio processor contains microphones that pick up sound and speech from the environment and convert them into a signal that can be transmitted across the skin to the implant. The signal transmitted by the Audio Processor is converted into controlled vibrations of the mastoid bone by the implant, which are perceived as sound.
Target Area
The patient's hearing will be affected by this device. Since it is an implant on the patient's skull behind the ear, the areas of the skull and skin over the implant will be affected, including the ear.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.3340
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.3340 Active implantable bone conduction hearing system

§ 874.3340 Active implantable bone conduction hearing system.

(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.

(8) Labeling must include:

(i) A summary of clinical testing conducted with the device that includes a summary of device-related complications and adverse events;

(ii) Instructions for use;

(iii) A surgical guide for implantation, which includes instructions for imaging to assess bone dimensions;

(iv) A shelf life, for device components provided sterile;

(v) A patient identification card; and

(vi) A patient user manual.

[83 FR 54009, Oct. 26, 2018]