Hearing

Main information

  • Trade name:
  • Hearing aid remote control
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Hearing aid remote control
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216524
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216524

Cochlear Ltd - Hearing aid remote control

ARTG entry for

Medical Device Included Class 1

Sponsor

Cochlear Ltd

Postal Address

1 University Avenue,MACQUARIE UNIVERSITY, NSW, 2109

Australia

ARTG Start Date

24/10/2013

Product category

Medical Device Class 1

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Cochlear Bone Anchored Solutions AB

Konstruktionsvagen 14

Molnlycke, , 435 33

Sweden

Products

1. Hearing aid remote control

Product Type

Single Device Product

Effective date

24/10/2013

GMDN

57885 Hearing aid remote control

Intended purpose

The Remote Control is to be used with Baha Sound Processors. It provides users a simple means of

adjusting program and volume settings, and to monitor the sound processor status, without touching or

removing the processor.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 04:58:58 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

5-10-2018

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA allows marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables the user to fit, program and control the hearing aid on his or her own, without assistance from a health care provider.

FDA - U.S. Food and Drug Administration

29-8-2014

Consultation: rules of procedure for public hearings in the EMA

Consultation: rules of procedure for public hearings in the EMA

The European Medicines Agency (EMA) has launched a public consultation on draft rules of procedures for public hearings held by its Pharmacovigilance Risk Assessment Committee (PRAC).

Danish Medicines Agency

5-10-2018

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release:  https://go.usa.gov/xPkuB 

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release: https://go.usa.gov/xPkuB 

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release: https://go.usa.gov/xPkuB 

FDA - U.S. Food and Drug Administration