S0003996

Hearing aid, adult, BTE-P, preprg


Preprogrammed behind-the-ear digital hearing aid. This electronic device amplifies and transmits sound for adults with mild-to-severe hearing loss. Designed to provide access to speech and aid in the perception of environmental sounds. This device is designed to be used in settings without appropriate resources and facilities available for hearing aid fitting and programming. It is designed to be an alternative on-the-spot fitting solution. This device is attached to the user’s ear through an earmold or dome. There are pre-configured sound profiles available to provide an adequate match to the user’s hearing loss.
Indicative Price 60.05 USD

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 mild-to-severe hearing loss.

TECHNICAL SPECIFICATIONS
Fitting range: mild-to-severe hearing loss of common audiometric configurations
Size 13 zinc-air battery
Fixed directional microphones
Noise reduction
4+ software adjustment bands
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 mobile fitting app available in English, French and Spanish for both iOS and Android systems
Low battery alert
Hypoallergenic casing
Left and right hearing aid indicators (e.g., colour coding)
Available in three different colours

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
Mobile fitting app (free and available for download on app store)
Consumables for regular upkeeping (e.g., hooks, domes, batteries)

ESTIMATED LIFE SPAN
Five years

WARRANTY
Two years

ENVIRONMENTAL CONDITIONS
Operating conditions: 0 °C to 50°C, relative humidity up to 93%
Storage conditions: -20°C to 45°C, relative humidity up to 80%
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
S0003995 Hearing aid, adult, BTE-SP, prg
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
Device has market clearance for:
CE Class IIa (EU)

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
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