Before the first implantable Cochlear™ Baha® System was launched, one of the only solutions available to those that could not benefit from air conduction hearing aids was bone conductors fitted to steel headbands or glasses. Although it is commonly agreed that a preoperative trial is important to provide candidates with realistic expectations,1-3 similar devices are still being used for patients testing bone conduction as part of the counselling process for an implantable solution. In 2002, the Baha Softband was developed by Cochlear as a solution for children that were too young, or not ready for an implantable solution. This device has sometimes been used as a demo solution, providing a more comfortable alternative to headbands or testbands. However, the aesthetics of the Softband do not appeal to everyone. Indeed, previous research has shown that the most common reason to reject the proposal of an implantable bone conduction solution is the cosmesis.4 It could be hypothesized that the use of steel headbands and the Softband as demonstration devices have created additional barriers to the adoption of an implantable solution. Clinicians have also raised concerns that for older children that reject the Softband due to aesthetics there is no alternative solution, which in the worst case may leave them without amplification. This whitepaper summarizes the outcomes from the testing performed on the Cochlear Baha SoundArc to ensure it meets the expectations of users and their hearing care professionals.
Design concept, technical verification and patient testing of the new Cochlear™ Baha® SoundArc (white paper)
1. Desmet J, Bouzegta R, Hofkens A, De Backer A, Lambrechts P, Wouters K, Claes J, De Bodt M, Van de Heyning P. Clinical need for a Baha trial in patients with single-sided sensorineural deafness. Analysis of a Baha database of 196 patients. Eur Arch Otorhinolaryngol. 2012; 269(3):799-805.
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Osia implant hearing rehabilitation in a patient with a chronically draining mastoid cavity
By Andrew J. Ebelhar, MD
The chronic mastoid cavity can present an additional obstacle for implantable hearing device rehabilitation of severe hearing loss. Endoscopic management of a radical mastoid cavity can be helpful in offering patient’s implantable solutions by limiting surgical incisions and reducing operative time.
Case Study
A 33 year-old female with a history of a canal wall down mastoidectomy as a child presented for evaluation of a chronically draining mastoid cavity and hearing loss. The patient stated that her ear had persistent purulent drainage since the operation. She had been evaluated by previous Otolaryngologists and had failed medical therapy at rehabilitating the mastoid cavity. She had never been able to wear a hearing aid due to the extensive drainage. Examination showed a very high facial ridge and deep mastoid cavity with purulence and granulation tissue present. The neotympanic membrane was retracted with no aerating of the middle ear space (Figure 1). Audiogram showed right ear masked bone conduction pure tone average of 21dB with air pure tone average at 93dB (Figure 2). The patient was offered right endoscopic subtotal petrousectomy and ear canal closure with second stage Osia® implant placement for hearing rehabilitation.
Figure 1 – Endoscopic view, right ear
The deep mastoid bowl with granulation is seen outlined with the thick black line. The high facial ridge is marked with the yellow “x” and the middle ear space with retracted squamous epithelium is outlined by the thin yellow line.
Figure 2 – Audiogram
Maximal conductive loss present on the right
An endoscopic transcanal technique was used to removal of all skin and squamous debris from the ear canal, mastoid cavity, and middle ear space. The bony surfaces were drilled to ensure all removal of skin and mucosal tissue. A modified Rambo flap was used to close the ear canal in a cartilaginous layer and then a skin layer. The patient had no postoperative issues and presented three months later for an endoscopic mastoidotomy and middle ear exploration and Osia implantation.
A post-auricular incision was used and the subcutaneous tissues elevated out of the mastoid. The endoscopic was introduced into the mastoid cavity and adhesions were lysed and the middle ear space visualized. Thorough inspection did not reveal retained squamous material. The Osia implant was then placed posterior to the mastoid cavity and the incision closed. The patient had an uneventful postoperative course and underwent activation of the Osia device four weeks after implantation. Follow up at one year showed a stable ear canal closure. She was very pleased with hearing results and the resolution of her persistent drainage!
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About the author: Dr. Ebelhar is originally from Owensboro, Ky., and attended Western Kentucky University for his undergraduate studies. He graduated from the University of Louisville School of Medicine in 2012 and completed his Otolaryngology (ENT-Head and Neck Surgery) in 2017 at the University of Kentucky. He is board certified in Otolaryngology-Head and Neck Surgery. He started the Med Center Health ENT Implantable Hearing Solutions program in 2017, offering both Cochlear Implants and Bone Anchored Hearing Aid implants. In 2020, he became one of the first surgeons in the country implanting the new Osia device.
6 things to remember about the Baha 6 Max Sound Processor
The Cochlear™ Baha® 6 Max Sound Processor is designed to improve hearing outcomes for people with SSD (single-sided deafness), conductive or mixed hearing loss.
Here’s what the Baha 6 Max offers:
- A premium-power sound processor: With a fitting range of up to 55 dB sensorineural hearing level (SNHL) in the same small size as current 45 dB devices, the Baha 6 Max is the first of its kind: a premium-power bone conduction sound processor designed for powerful hearing performance.1
- Tuned for high frequencies. Research suggests that an extended bandwidth can improve recognition of high-frequency consonants in quiet and in noise.2,3 The Baha 6 Max has a new high-powered Xidium™ platform with a frequency range up to 9.85 kHz.**
- More connectivity: It’s also the first bone conduction sound processor to offer direct streaming from Apple® and Android™ devices* The new sound processor provides additional power in the smallest form and is designed to provide the most clear, rich and natural sound possible, reducing the need to choose between hearing performance and size.1,5
- Even more discretion: 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 head, so it sits closer to the head than other traditional bone conduction devices.4
- Dust and water protected: The Baha 6 Max Sound Processor has the highest dust and water-resistance with an IP68-rating.6,7‡
- Remote Care ready: Remote Care† gives you the flexibility to deliver quality care without your patients making a trip to the clinic – fitting into your patients’ lives and your schedule. Patients can conveniently access Remote Care through their compatible smartphone* at home, at work, or when they’re away.
For more information on bone conduction solutions, subscribe to Cochlear ProNews.
References:
- Hua H. Baha 6 Max fitting range. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1725632.
- 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 20;1-12.
- Snapp HA et al. Effects of extended high frequency bandwidth in osseointegrated bone conduction device users. Hearing Research. 2021 [In press]
- Land J. Comparison tech data Baha 6 Max, legacy and competition. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1762475.
- Hoffman J. Subjective evaluation of clear rich and natural sound. Cochlear Bone Anchored Solutions AB, Sweden. 2020; D1788013.
- Andersson H. Baha 6 Max IPx8 Test Report. RISE Research Institutes of Sweden AB, Sweden. 2020; D1757477.
- Andersson H. Baha 6 Max IP6x Test Report. RISE Research Institutes of Sweden AB, Sweden. 2020; D1757476.
In the United States and Canada, the placement of a bone-anchored implant is contraindicated in children below the age of 5.
*The Cochlear Baha 6 Max Sound Processor is compatible with Apple and Android devices. The Cochlear Baha Smart App is available on App Store and Google Play. For compatibility information visit www.cochlear.com/compatibility
**With the Baha Connect System.
‡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.
† Clinic must be enrolled in Remote Care to participate.
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.