Cochlear Receives FDA Clearance for Baha 6 Max Sound Processor

LONE TREE, COLORADO— Cochlear Limited (ASX: COH), a global leader in implantable hearing solutions, announces the U.S. Food and Drug Administration (FDA) clearance of the new Cochlear™ Baha® 6 Max Sound Processor, designed to improve hearing outcomes for people with SSD (single-sided deafness), conductive or mixed hearing loss.

With a fitting range of up to 55 dB SNHL (sensorineural hearing level) in the same small size as current 45 dB devices¹, the Baha 6 Max is the first of its kind: a premium-power bone conduction sound processor designed for powerful hearing performance. The Baha 6 Max is also the first bone conduction sound processor to offer direct streaming from Apple® and Android™ devices.² 

Direct streaming from Apple devices has been available in the Baha 5 Sound Processor since 2015. The new processor provides additional power in the smallest form^1,3 and is “designed to provide the most clear, rich and natural sound possible–reducing the need to choose between hearing performance and size”.

 

Cochlear Baha 6 Max

 

Additional improvements of the Baha 6 Max over the previous generation Baha 5 Sound Processor include:  

• New noise and feedback reduction features
• Frequency range up to 9.7 kHz
• Streamlined profile by up to 2 mm¹
• IP68-rating dust and water protection*
• 50 percent longer battery life⁴
• Baha Smart App compatibility with Apple Watch®⁵
• Child-friendly features, including LED indicator
• New mint color option for sound processor front

“We at Cochlear continue to be inspired by all our recipients who get to experience fulfilling, active lives full of connection, and we innovate new products to help enable their success. As such with the Baha 6 Max, we have delivered a leap forward in bone conduction hearing technology, providing more power in the industry’s smallest bone conduction sound processor with greater connectivity and hearing features. Our goal with this new device is to continue bringing a hearing experience full of clear, rich and natural sound, while introducing new elements that aim to make great hearing an even more seamless part of everyday life.”

—Tony Manna, President, Cochlear Americas

 

Further feature highlights

 

• Improved hearing in noise: Cochlear has more than 40 years of experience in bone conduction hearing solutions, and its market research shows most recipients want to improve their ability to hear in noisy environments.⁶

Research suggests extended bandwidth can improve recognition of high-frequency consonants in quiet and in noise⁷, so the new, high-powered Xidium™ platform in the Baha 6 Max features a frequency range of up to 9.7 kHz. In a study, participants using the Baha 6 Max showed a significant improvement in understanding speech in both quiet and noisy environments compared to the Baha 5 Sound Processor.⁸ 

Cochlear’s SmartSound™ iQ signal processing suite boasts new impulse noise reduction and improved feedback management. Along with other features such as the scene classifier and active gain adjustment, this advanced signal processing technology aims to deliver a clear signal, helping the user fully take in their surroundings. The Baha 6 Max showed a significant difference in terms of sound clarity (more than 35 percent improvement) and sound quality (more than 25 percent improvement) when compared with the Baha 5 Sound Processor.⁸

• More power: Usage data from market research suggests many users of bone conduction devices may be underfit, and therefore may benefit from additional dynamic hearing range⁶, which provides capacity should a person’s hearing loss worsen over time. The new BC Drive™ II transducer, which powers the Baha 6 Max, is twice as efficient than the BC Drive on the Baha 5 Sound Processor, delivering 7 dB more average maximum power.⁹
  
  
• Greater connectivity: In addition to being the first bone conduction sound processor with direct audio streaming from Android and Apple devices, the Baha 6 Max is compatible with the Baha Smart App and allows users to connect to an Apple Watch, so they can discreetly fine-tune their sound processor settings. The Smart App also offers additional options to personalize hearing, including the expanded three-band equalizer and settings to customize noise reduction.
  
  
• System readiness: The Baha 6 Max Sound Processor introduces system readiness for our expanding connected care portfolio.
  
  
• Designed with children in mind**: An LED indicator allows parents, clinicians and carers to be sure the processor is turned on and connected. The small size of the Baha 6 Max makes it a discreet solution for children and adults, and the new LowPro™ snap coupling even brings the device 2 mm closer to the head¹, so it sits closer to the head than other bone conduction devices. The Baha 6 Max is also designed to keep up with active children, with its IP68 dust- and water-protection rating. For clinicians, the new Baha Fitting Software 6.0 introduces new workflows to guide fittings, as well as options to customize settings to the child’s specific needs.

“The Baha 6 Max was designed as a direct response to the needs of patients who are looking for improved hearing performance in their hearing device but want the smallest device possible,” said Anna Anderström, Group Lead Bone Conduction Solutions, Cochlear Americas. “With an all-new transducer, we were able to increase the power output while keeping the size down. This is also a benefit to our pediatric population where early access to hearing is so important for language development.”

The Baha 6 Max Sound Processor, Baha Fitting Software 6.0 and Baha Smart App are already approved in Canada. The Baha 6 Max Sound Processor will be commercially available across the United States and Canada in the first half of 2021.

_References

1. _{Land J. Comparison tech data Baha 6 Max, legacy and competition. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1762475.}
2. _{The Cochlear Baha 6 Max Sound Processor is compatible with Apple and Android devices. For compatibility information, visit www.cochlear.com/compatibility.}
3. _{Hoffman J. Subjective evaluation of clear rich and natural sound. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1788013.}
4. _{In an average use case at similar prescriptions. Davidsson B. Technical Report: Battery autonomy in Baha 6 Max vs Baha 5. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1770958.}
5. _{The Cochlear Baha Smart App is available on App Store and Google Play.}
6. _{Leung B. Technical Report: Baha 6 Max data analysis and correlation report. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1772435.}
7. _{Van Eeckhoutte M, Folkeard P, Glista D, Scollie S. Speech recognition, loudness, and preference with extended bandwidth hearing aids for adult hearing aid users. Int J Audiol. 2020;1-12.}
8. _{Hua H. Baha 6 Max Home test CIR CBAS5779. Cochlear Bone Anchored Solutions AB, Sweden. 2021; D1801512.}
9. _{Bergs T. Technical Report: Performance comparison A1 vs A2 actuators. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1770991.}

_{* The Cochlear Baha 6 Max Sound Processor, with battery compartment excluded, is dust and water resistant to level IP68 of the International Standard IEC60529. Refer to the relevant user guide for more information. Tested by the RISE Research Institutes of Sweden AB.}

_{** In the United States and Canada, the Baha Implant System is contraindicated in children below the age of 5.}

_{Android, Google Play and the Google Play logo are trademarks of Google LLC.}

_{Apple, the Apple logo, Apple Watch, iPhone, iPad and iPod are trademarks of Apple Inc., registered in the U.S. and other countries.}

_{Please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.}

_{© Cochlear Limited 2021. All rights reserved.}

 

About Cochlear Limited (ASX: COH)
Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 4,000 people and invests more than AUD$180 million each year in research and development. Products include cochlear implants, bone conduction implants and acoustic implants, which healthcare professionals use to treat a range of moderate to profound types of hearing loss. Since 1981, Cochlear has provided more than 600,000 implantable devices, helping people of all ages, in more than 180 countries, to hear.

 

Source: Cochlear