There's great concern that there is no control in the UK, Europe and the United States on the sale of Personal Sound Amplification Devices. These are (usually) inexpensive products which are worn in or on the ear which simply amplify sound but are being seen incorrectly as an alternative to hearing aids.
These devices look very similar to hearing aids but are not subject to the essential regulations associated with medical devices: consequently they can be bought over the counter in any store which chooses to stock them, without the purchaser having to go through a GP or a registered Hearing Aid Dispenser.
All the devices that have been tested to date lack controls to limit power output output and have been tested with output levels between 125 and 135 dBSPL, some 40-50 dB higher than acceptable levels. Operating at these power levels, maximum “safe” exposure to these devices might be as low as two seconds per day, posing an unacceptable threat to the safety of unsuspecting consumers. There is little guidance on these devices to indicate potential hearing damage.
Our colleagues in the European Association of Audiologists (AEA) with the European Federation of Heard of Hearing People (EFHOH) has produced a paper outlining the risks of these devices to support its campaign to seek European legislation, and BSHAA has lobbied the British Government. The documents are also used to support colleagues in the United States, who share our concerns, and to inform the World Health Organisation's “keep listening safe” project.
You can download:
AEA EFHOH Paper on Personal Sound Amplification Products 12 15 final
AEA EFHOH Paper on Personal Sound Amplification Products Annexe 12 15
BSHAA's letter to Health Under secretary, George Freeman