Hearing aid, adult, BTE-SP, prg

GENERAL DESCRIPTION
Digital programmable BTE (behind-the-ear) hearing aid for people with hearing loss.

INTENDED USE
Designed to be worn behind-the-ear for people with a moderate-to-profound hearing loss.

TECHNICAL SPECIFICATIONS
Fitting range: moderate-to-profound hearing loss of varying audiometric configurations
Size 675 zinc-air battery
Directional microphones
Adaptive noise reduction
4+ software adjustment bands
Four additional programs
Compression system
Feedback management system
Manual volume control
Battery door acts as on/off switch
Battery door marked with the “+” symbol to indicate the location of the positive terminal
Water-repellent coating
Compatible fitting software and interface available in English, French and Spanish
Telecoil facility
Low battery alert
Hypoallergenic casing
Left and right hearing aid indicators (e.g., colour coding)
Available in three different colours
Bluetooth compatibility (depending on the brand supplied)

SUPPLIED WITH
1 x hearing aid storage container
1 x set of hearing aid cleaning tools (e.g., small brushes and wires)
1 x dry aid kit (2 x additional packs of drying beads)
3-month supply of hearing aid batteries as per estimated battery life for the model offered
1 x set of acoustic couplings
1 x set user manual in English, French or Spanish.

ITEMS REQUIRED, BUT NOT SUPPLIED
Programming software
Programming cables and/or wireless programming interface
Consumables for regular upkeeping (e.g., hooks, domes, batteries)

OPTIONAL ACCESSORIES AVAILABLE (at additional cost)
Depending on the model additional accessories can be offered, such as
Pre-set custom earmolds
Spare batteries
Cleaning tools

ESTIMATED LIFE SPAN
Five years

WARRANTY
Two years

ENVIRONMENTAL CONDITIONS
Operating conditions: 0 °C to 45°C, relative humidity up to 90%
Storage conditions: -20°C to 45°C, relative humidity up to 90%
Ingress protection: IP 68 (depending on the brand supplied)
Atmospheric pressure: 700-1060 hPA

WEIGHT AND VOLUME (Packaged)
Weight: 0.38 kg
Volume: 1.309dm³

FITTING / PROGRAMMING REQUIREMENTS
Refer to programming guide and user manual for specific set-up instructions. Contact information for technical support is available for each manufacturer. Fitting and programming should be done by a trained hearing instrument practitioner.

MAINTENANCE/USER REQUIREMENTS
Refer to user manual for specific precautions and maintenance requirements.

ALTERNATIVE PRODUCTS
S0003994 Hearing aid, adult, BTE-P, prg
S0003996 Hearing aid, adult, BTE-P, preprg
S0003997 Hearing aid, child, BTE-P, prg
S0003998 Hearing aid, child, BTE-SP, prg

USEFUL LINKS
Deafness and Hearing Loss:
https://www.who.int/news-room/fact-sheets/detail/deafness-and-hearing-lo ss#:~:text=A%20person%20who%20is%20not,moderate%2C%20severe% 2C%20or%20profound.

Types of Hearing Loss:
https://www.cdc.gov/ncbddd/hearingloss/types.html

Hearing Aids General Information:
https://www.nidcd.nih.gov/health/hearing-aids#:~:text=Behind%2Dthe%2Dear %20(BTE,earmold%20and%20into%20the%20ear

Hearing Aids General Information: For Children
https://www.ndcs.org.uk/information-and-support/childhood-deafness/heari ng-aids/how-do-hearing-aids-work/

Information on hearing aid batteries:
https://successforkidswithhearingloss.com/wp-content/uploads/2014/06/Bat tery-Facts.pdf

QUALITY MANAGEMENT SYSTEM
Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.

CLASSIFICATION
Depending on the model the device has market clearance for:
- CE Class IIa (EU)
- GMPALS (Australia)
- Device License Canada
- 510(k) Device Letter Class II Medical Device (USA)

SAFETY AND PRODUCT STANDARDS
IEC 60118 Electroacoustic - Hearing aids.
ANSI/ASA S3.22-2014 Specifications of Hearing Aid Characteristics

NOMENCLATURE
GMDN code(S):
- 34671 Air-conduction hearing aid, behind-the-ear
- 46539 Hearing aid battery