Medical Device Manufacturer Catalog No.8009

OROSOL^® can produce medical device – Hearing Aids & Audiology Solutions.

Item Name: OROSOL^® Hearing Aids & Audiology Solutions.

Brand: OROSOL^®

OROSOL^® can produce all kinds of medical devices.

If you are interested in this product, please feel free to contact us: RoboticWorkCell@outlook.com

Product Description

Medical Device Manufacturer Catalog No.8009

General View of OROSOL^® Manufacturer No.8009:

OROSOL Machinery and Equipment Manufacturing LLP is located in China, with Manufacturer No.8009 a modern manufacturing facility spanning over 30,000 square meters. The company employs more than 400 professional staff members, including a dedicated R&D team of over 80 engineers and technicians specializing in audiology technology, digital signal processing, and hearing aid development. Founded in 2004, the company is a nationally recognized “Specialized and Sophisticated” Little Giant Enterprise and China’s only hearing aid manufacturer selected as a “China Manufacturing Hidden Champion” in 2022. The company invests 7% of annual sales revenue in R&D and holds over 70 national technology patents. With an annual production capacity of 400,000 units, products are exported to more than 110 countries and regions worldwide. The company has obtained ISO 13485, CE, and FDA international certifications.

Medical Device Product Catalog No.8009:

Product Category	Product Name & Model	Parameters & Specifications	Features & Applications
Rechargeable Hearing Aids	OS-HA-1000 Rechargeable Lithium Battery BTE Hearing Aid	Battery: Dedicated lithium rechargeable battery; Runtime: Up to 20 hours per full charge; Charging case included; Digital signal processing; Available in multiple gain levels; CE and FDA certified; IPX5 water resistance.	Industry’s first professional lithium battery rechargeable hearing aid, launched in 2013. Eliminates the need for frequent battery replacement. Ideal for users seeking convenience and environmental sustainability. Suitable for mild to moderate hearing loss.
Smart Hearing Aids	OS-HA-2000 Smart Remote Fitting Hearing Aid System	Wireless connectivity via App; Volume/program/band/frequency adjustment via smartphone; Remote expert consultation and fitting via mobile App; Available in BTE, ITE, and TWS form factors; CE and FDA certified.	Industry-first smart remote fitting hearing aid, launched in 2018. Users can self-adjust and receive remote professional fitting services. Suitable for users who require flexible, convenient fitting and after-sales support.
Smart Hearing Aids	OS-HA-3000 AI-Powered Smart Hearing Aid (SoundWear Primo RMA801 MP)	Dual-core processing (AI chip + DSP chip); SWAI lossless noise reduction; AI-powered automatic environment detection and adaptation; Deep Neural Network (DNN) noise reduction algorithm; Remote fitting via App support; Available in BTE and ITE form factors.	Advanced AI hearing aid with dual-core architecture for real-time environmental classification and speech enhancement. Provides superior noise reduction and speech clarity. Suitable for users with moderate to severe hearing loss in complex listening environments.
Smart Hearing Aids	OS-HA-4000 OTC Hearing Aid with Custom Fitting Technology	Direct-to-consumer (OTC) design; App-based self-fitting and customization; Preset and customizable hearing programs; Available in BTE and ITE form factors; Smartphone App remote control support.	OTC hearing aid with custom fitting technology, launched in 2022. Designed for consumers who require affordable, accessible hearing solutions. Supports self-fitting via App for personalized hearing experience.
Wireless & Connected Hearing Aids	OS-HA-5000 True Wireless Bluetooth Hearing Aid	Bluetooth connectivity for audio streaming; Wireless charging case; Noise reduction algorithms; Smartphone App control; Available in TWS and BTE form factors; Voice call and media streaming support.	True wireless Bluetooth hearing aid with integrated audio streaming capability. Connects to smartphones for hands-free calling and media streaming. Suitable for users who want seamless connectivity and multifunctional hearing devices.
Wearable Hearing Solutions	OS-HA-6000 Smart Eyewear with Integrated Hearing Aid	Hearing aid integrated into eyeglass frame; Bluetooth connectivity; App-based remote control; Rechargeable battery; Available in various frame styles and colors; Prescription lens compatible.	Innovative hearing aid integrated into eyewear, launched in 2020. Combines vision and hearing solutions for users who require both optical correction and hearing assistance. Discreet, stylish, and functional.
Hearing Aid Accessories	OS-HA-7000 Hearing Aid Remote Fitting & Management App Ecosystem	Compatible with iOS and Android devices; User-side App: independent volume, program, band, frequency adjustment; Expert-side portal: remote fitting and consultation; Multiple language support; Integrated hearing assessment function.	Comprehensive App ecosystem for remote hearing aid fitting and management, launched in 2019. Supports both user self-adjustment and professional remote fitting. Reduces fitting costs and improves accessibility.
Hearing Aid Accessories	OS-HA-8000 Hearing Aid Wireless Charging Case	Integrated lithium battery; Supports wireless charging; Compact and portable design; LED charging status indicator; Compatible with multiple hearing aid models; Provides up to 3 full charges.	Convenient wireless charging case for rechargeable hearing aids. Enables on-the-go charging for extended usage. Suitable for users who need portable charging solutions for travel and daily use.

Certificates of OROSOL^® Medical Device Manufacturer 8009:

ISO 13485:2016 — Medical Devices Quality Management System (Certified by German MED/CERT)
FDA 510(k) Clearance — Hearing Aids (Class II) — US Market Access
CE Marking (MDR 2017/745/EU) — Compliance with European Medical Device Regulation
NMPA Medical Device Registration Certificate — Ear-level Hearing Aids HY-BE025~HY-BE038, HY-BE039~HY-BE063 (Class II)
GMP Certification — Good Manufacturing Practice for Medical Devices (China NMPA)
National “Specialized and Sophisticated” Little Giant Enterprise — Third Batch, Ministry of Industry and Information Technology (2021)
China Manufacturing Hidden Champion — Only hearing aid manufacturer selected (2022)
National High-Tech Enterprise Certification (China)
Over 70 National Technology Patents — Including invention patents, utility model patents, and design patents
NMPA Medical Device Master File Registration — Hearing Aid Digital Signal Processing Technology
ISO 9001:2015 — Quality Management System (Certified)
RoHS Compliant — Restriction of Hazardous Substances Directive (EU)
REACH Compliant — Registration, Evaluation, Authorization and Restriction of Chemicals (EU)