Hearing aid, adult, BTE-P, prg

GENERAL DESCRIPTION
Digital programmable BTE (behind-the-ear) hearing aid for adults with mild to severe hearing loss.

INTENDED USE
To provide amplified and frequency-adjusted sound to individuals with hearing loss, supporting improved communication, learning, and participation in daily activities.

TECHNICAL SPECIFICATIONS
Fitting range: Mild-to-severe hearing loss of varying audiometric configurations.
Battery type: Size 13 zinc-air battery (disposable)
Compression system
At least 6 compression channels
Minimum of 4 software adjustment bands
Manual volume control
Battery door as on/off switch
Battery door marked with "+" symbol to indicate the location of the positive terminal
Alerts for low battery
Directional microphones
Adaptive noise reduction
Feedback management system
Compatible fitting software and interface available in English, French and Spanish
4 additional fitting programs
Water repellent coating
Hypoallergenic casing
Left and right ear indicators
Available in at least 2 different colour options
iOS and android streaming capability
Bluetooth compatible
Available prescriptions in fitting software include (at minimum): DSL v5, NAL-NL1, NAL-R, NAL-NL2
Telecoil facility

TECHNICAL PERFORMANCE REQUIREMENTS
ANSI S3.22-2014 measures in 2cc coupler
Maximum OSPL 90: ≥ 130 dB SPL
OSPL 90 at HFA: ≥ 122 dB SPL
Maximum full-on acoustic gain: ≥ 70 dB SPL
Full-on acoustic gain at HFA: ≥ 62 dB SPL
Basic frequency response: at least 100-4940 Hz
Total harmonic distortion at 70 dB SPL input: 500 Hz < 2.8%, 800Hz < 0.4%, 1600 Hz < 0.4%
Equivalent input noise at 1kHz: ≤ 24 dB SPL
Battery current drain for quiescent/operating conditions: ≤ 1.7/1.9mA
Telecoil sensitivity: ≥ 101 dB SPL with a phone; ≥ 92 dB SPL with a loop system

SUPPLIED WITH
1 x user manual in English
1 x hearing aid storage container
1 x set of acoustic couplings
1 x set of hearing aid cleaning tools (e.g., small brushes and wires)
At least 24 battery cells.
1 x dry aid kit (includes drying jar and 2 additional packs of drying beads) depending on the supplied model.

OPTIONAL PACKAGING CONFIGURATION
In case of combination of 2 devices per pack, the packaging contains:
1 x user manual in English
2 x hearing aids
1 x set of acoustic couplings for each hearing aid
1 x hearing aid storage container for each hearing aid
1 x set of hearing aid cleaning tools (e.g., small brushes and wires)
At least 72 battery cells.
1 x drying jar and 3 packs of 2 drying beads depending on supplied model.

ESTIMATED LIFE SPAN
5-7 years

WARRANTY
At minimum, 2 years from date of shipment.

ENVIRONMENTAL CONDITIONS (at minimum)
- Operating conditions: 0°C to 45°C / ≤ 90% RH
- Storage conditions: -20°C to 60°C / 10 to 90% RH
- Ingress protection rating: IP68

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

MARKET CLEARANCE AND DEVICE CLASSIFICATION
The models covered under this material have one or more of the following approvals, depending on the specific device supplied:
CE certified as Class IIa device.
US FDA Market clearance (class II) – 510k
Health Canada Medical Device Licence (Class II)

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

NOMENCLATURE
-GMDN ©: Air-conduction hearing aid, behind-the-ear (34671)
-EMDN: Hearing aids, behind-the-ear (Y214506)