TECH Talk: Early Cochlear™ Osia® System experience

What is implant stability and why does it matter?

By Shawn Enter

Dating back to the 1950s, Swedish Professor P-I Branemark pioneered the study of titanium and its osseointegration qualities.  His research was advanced by Dr. Anders Tjellstrom’s work on bone conduction hearing implants.  Throughout the decades, titanium has served as the metal of choice for hearing implants.  Today, Cochlear offers the most advanced titanium implant in the Baha® 300 Series implant.  The BI300 implant boasts the TiOblast^™ surface for faster/stronger osseointegration and secondary stability when compared to previous implants. It has small sized threads for optimal load distribution and a wider profile of 4.5mm to optimize strength of the system.  These attributes allow clinically proven long-term stability.^{1, 2} The chart below shows 5-year follow up data of primary and long-term strength of osseointegration with the Baha 300 Series implant. 

Whether a sound processor is actively loaded on a Baha Connect system or passively loaded on a Baha Attract system, your patients will benefit from the most advanced titanium bone conduction implant available; the Baha 300 Series implant.

The Importance of DermaLock™

By Kelly Crettol

The Cochlear® Baha® Connect System is a well-proven percutaneous bone conduction implant system allowing direct, single-point sound transmission via a minimally invasive skin-penetrating abutment.

Conventional titanium abutments have been used for 40 years, but despite titanium’s well established ability to osseointegrate with bone, it does not integrate with the surrounding tissue. As a result, bone conduction implant surgery previously involved substantial soft tissue reduction to facilitate successful outcomes. Consequently, viable structures of the soft tissue were permanently removed affecting the healing capacity of the local immune system. The Cochlear® Baha® BA400 Abutment with DermaLock^™ technology features a plasma-sprayed hydroxyapatite (HA) coating and concave design that promotes soft tissue adherence and stability.³ 

Hydroxyapatite (HA) has been shown to provide enhanced dermal adhesion, diminishing epidermal downgrowth and pocket formation, and thus allowing for preservation of the soft tissue during surgery. This technology helps preserve the hair and skin around the abutment which not only leads to improved aesthetics and reduced numbness, but also dramatically reduces surgery time and benefits healing through increased vascularization of soft tissue.⁴

Download our Baha Connect and Attract Systems 2-pager to learn more about Baha Systems.

About our guest authors:

Shawn Enter, Regional Surgical Training Manager at Cochlear Americas

Shawn is responsible for training surgeons and OR staff in the Cochlear Implant, Baha and Vistafix product lines.  He also supports complicated surgical scenarios and assists in new product launches.  Shawn joined Cochlear as an Area Business Manager and has worked in the Surgical Specialist role over the last five years.  Prior to joining Cochlear in January of 2010, Shawn provided surgical training and support in the Orthopedic industry for DePuy Mitek and Stryker.

Kelly Crettol, Surgical Education Manager at Cochlear Americas

Previously, she was a RSTM for the West Region and has been with Cochlear since February 2016. In her new role, Kelly is responsible for the development and execution of Cochlear’s surgical and fellowship education programs which includes development of educational content, implementation, promotion and assessment of surgical education programs.  She is also responsible for the coordination and collaboration with both internal colleagues and professional partners, including KOLs.

Kelly has over twelve years of experience in pharmaceutical and medical devices sales from prior organizations. Kelly graduated from Pennsylvania State University with a B.S. in Psychology.

References:

1. den Besten CA, Stalfors J, Wigren S, Blechert JI, Flynn M, Eeg-Olofsson M, Aggarwal R, Green K, Nelissen RC, Mylanus EA, Hol MK. Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing: Long-Term Follow-Up of a Randomized Controlled Trial. Otol Neurotol. 2016;37(8):1077-1083.

2. Sennerby L, Gottlow J, Rosengren A, Flynn M. An experimental evaluation of a new craniofacial implant using the rabbit tibia model: Part II. Biomechanical findings. Otol Neurotol. 2010;31(5):840-845.

3. van Hoof M, Wigren S, Duimel H, Savelkoul PH, Flynn M, Stokroos RJ. Can the Hydroxyapatite-Coated Skin-Penetrating Abutment for Bone Conduction Hearing Implants Integrate with the Surrounding Skin? Front Surg. 2015;2:45.

4. Iseri M, Orhan KS, Yariktas MH, Kara A, Durgut M, Ceylan DS, Guldiken Y, Keskin IG, Deger K. Surgical and audiological evaluation of the Baha BA400. J Laryngol Otol. 2015;129(1):32-37.

Clinical History and Description

Sam was born with bilateral atresia and microtia and was adopted at four years of age. His family history and previous audiological information are unknown. His adoptive mother did report previous imaging to her knowledge was consistent with missing ossicles. He did arrive to his adoptive family wearing a bone conduction hearing device fit to a Softband. This device was fit unilaterally and was a loaner device from a charity organization. It is unknown when an Audiologist had fit the loaner Softband on Sam. He was placed in a total communication (TC) classroom when he started school. His mother reports that he had no intelligible words at the time of his adoption.

Audiological Testing

At five years and seven months of age, Sam was seen at Cook Children’s Medical Center in Fort Worth, Texas by Audiology and ENT. His ENT physician ordered an updated CT scan and the results were as follows: bilateral microtia and atresia, bilateral dysplastic ossicular chain, bilateral lateral SCC/vestibular abnormalities, mild narrowing basal turn right cochlea, and abnormal location of facial canal. Audiological results were consistent with a moderate conductive hearing loss for both ears (See Table 1). Audiological recommendations were to fit Sam with a bilateral Cochlear^™ Baha^® 5 on a Softband until further surgical/medical decisions were made.

 Table 1. Unaided Test Results Initial Audiological Evaluation

Sam was fit with two Baha 5 processors on a bilateral Softband two months after initial audiological testing at Cook Children’s Medical Center. Aided testing for Sam utilizing the bilaterally fit bone conduction devices revealed thresholds within the slight hearing loss to normal hearing range in sound-field.

Sam was evaluated again at a one-month follow-up appointment (See Table 2). During this follow up appointment, Sam’s mother reported a vast change in hearing and listening abilities after the bilateral fitting. The family reported that Sam could now say all his family members’ names and follow many auditory commands at home. Sam was given a SoundArc during this appointment after his mom reported that he complained about his hair sticking out with the Softband.

Table 2 – Aided Results at 1 Month

At four months after initial fitting of the Baha, Sam’s mother reports a “HUGE improvement using two Bahas versus one Baha” and he continues to use two Baha 5 sound processors with his SoundArc daily. After the improvements seen by the family, Sam was moved from a total communication hearing impaired program into a regular public school. Sam’s family reported this school transition has been amongst the biggest issues they have worked through over their first year with Sam. In the new school, Sam is required to use his voice and not depend on sign language for communication. His mom reported ‘second guessing’ their decision to move Sam as they had gone against the advice of his previous school. However, they have seen Sam excel so quickly they are now very proud of their decision. Sam has had a huge improvement in his speech and his family reports that he seems more confident and happy at home also. They also report that at home Sam has begun to initiate conversations with his family independently now.

Thoughts for the Reader

• For what patients would you consider a bilateral fitting over a unilateral fitting?

• What families and patients would you consider a SoundArc over a Softband?

• What are some additional educational or speech considerations needed for patients with delayed access to amplification?

• When there are slightly poorer aided results at 4000 Hz or otherwise with Softbands or SoundArc, what would be the impact on the child’s speech and language development? How can this be addresses audiologically?

• At what point would you consider suggesting a surgical option for Sam now that he is over 5 years of age? What clinical and social factors might play into this decision? At what point would you start discussing a surgical option with the family? How would you explain the potential benefits of transitioning to a surgical option to Sam and his family?

Learn more about Cochlear’s bone conduction solutions including the Baha 5 portfolio!

About our guest author: Lisa Christensen, AuD, is the Audiology Program Manager at Cook Children’s Medical Center in Fort Worth, Texas and currently serves as President of the American Academy of Audiology.

In the United States and Canada, the placement of bone-anchored implant is contraindicated in children below the age of 5 years.

Views expressed are those of the individual. Consult your hearing health provider to determine if you are a candidate for Cochlear technology. Outcomes and results may vary. Click here to view more.

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