Cochlear Implants
by Ryan Lopez

Cochlear expands treatment options for individuals with single-sided deafness

March 24, 2022
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By Ryan Lopez, Director, Nucleus Product Management & Marketing

In January 2022, Cochlear received FDA approval to treat patients with single-sided deafness (SSD) with the Cochlear™ Nucleus® System. This approval expands treatment options to include both bone conduction solutions and cochlear implants for these patients.

“This indication allows patients experiencing UHL/SSD to get as close to the normal condition as possible as a cochlear implant restores hearing ability to the ear that has hearing loss. This allows me to provide for my patients so they can get back to the condition that they had been used to before their hearing loss.”

-Eric Lupo, MD Rocky Mountain Ear Center

While this is an extremely important landmark, we want to ensure that professionals have the resources they need to provide the best treatment option for each individual’s unique hearing loss and needs. The first step in the counseling process is to help candidates understand the potential impact of single-sided deafness within their daily lives. While individuals with SSD can function well in relatively easy listening situations, bringing awareness to the disruption in their ability to understand speech in adverse listening situations, their ability to localize sound, and the mental fatigue associated with daily listening efforts, is vital.

Age and duration of hearing loss is a key consideration and starting point for determining the best solution for individuals with single-sided deafness. For children under five years of age, Cochlear offers Softbands and SoundArcs™, non-surgical bone conduction solutions. This is important because early access to improving speech understanding is of highest priority. For children ages five to twelve, Cochlear expands the bone conduction offering with the Baha® Connect and Attract Systems, as well as a portfolio of Nucleus cochlear implant solutions. Finally, for individuals twelve and older, in addition to cochlear implants, the Cochlear Osia® System combines the best high frequency amplification with unique piezoelectric stimulation without a percutaneous abutment.

With regard to cochlear implants, one of the core advantages is the restoration of binaural hearing and improved ability to localize. Candidacy is dependent on the presence of a functioning nerve in the impacted ear and a duration of less than 10 years since the onset of the hearing loss. With acoustic neuroma being one of the leading causes of unilateral hearing loss, the FDA has approved Cochlear to remove the acoustic neuroma contraindication from its labeling.

This ensures that individuals with a functioning nerve, pre- or post-acoustic neuroma removal, can still have a cochlear implant option.

With more options come more decision points. This is why we’re committed to partnering with leading professionals in the industry and developing clinical guidance tools to support you and your patients throughout the journey to better hearing

Please reach out to your local Cochlear Representative to learn more about these solutions and clinical guidance resources.

Read more about the treatment pathway for SSD patients here.

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Cochlear Case Studies – Use of Contour Advance Electrode with Dr. David Friedmann

April 12, 2021

By David Friedmann, MD, MSc

Cochlear Case Studies is a new series on Cochlear ProNews that highlights relevant clinical and surgical scenarios surrounding the latest hearing industry topics and research. We’re excited to partner with professionals to highlight their experiences surrounding specific patients. This first installment will specifically feature surgeons, their cases and contributing factors for use of different electrodes.

Case Study

Patient background

This patient is a middle-aged male with a long history of bilateral otosclerosis first diagnosed in his 20’s when he began wearing hearing aids. In otosclerosis, a bone disease which affects the otic capsule, both conductive hearing loss and sensorineural hearing loss can occur—especially as the disease progresses. Stapes middle ear surgery and hearing aids can address the conductive component of the hearing loss. With a profound mixed loss, it may be difficult to achieve the necessary level of amplification for adequate audibility with hearing aids alone. In such cases, stapes surgery may improve aidability with amplification. In cases where speech discrimination remains poor, a cochlear implant can be considered.

In this particular patient, he reported declining benefit from his bilateral hearing aids and had become more dependent on speech reading with minimal open set speech understanding with hearing aids. With no prior ear surgery, we discussed the role of stapes surgery for his profound mixed loss to improve his ability to wear hearing aids. Surgery was attempted on his worse hearing RIGHT ear which partially closed his air-bone gap and led to improved “aidability” with his hearing aids. This led to improvement in his aided word recognition score bringing it to 34%. We subsequently discussed his options for stapes surgery or a cochlear implant for his contralateral LEFT ear, but overall expectations were tempered given his advanced otosclerosis.

Candidate evaluation

Preoperative audiogram demonstrated bilateral profound loss (suspected mixed component in both ears) with normal tympanograms and unaided aided speech discrimination of 34% in RIGHT (ear with prior stapes surgery) and 0% in LEFT ear at 100 dB HL (MCL). Aided scores were 40% on RIGHT and 14% on LEFT.  After thorough discussion with the patient about outcomes with otosclerosis, the decision was made to implant the LEFT ear with a cochlear implantation.

Electrode selection

Given concerns for cochlear otosclerosis, a Contour AdvanceTM (512) was used for two main reasons. The stiffness of the stylet provides the opportunity to insert in the setting of partial ossification or fibrosis. Additionally, based on our Center’s experience, perimodiolar electrodes are preferred in cases of cochlear otosclerosis as the array resides further from the lateral wall where spread of current can lead to facial nerve stimulation from the cochlear implant. This reduces the likelihood of the facial nerve being stimulated by the cochlear implant.

Surgical observation

There was ossification at basal end which was easily removed revealing a patent lumen. Given this, the depth gauge was not necessary. The electrode array was inserted using the Advance Off-Stylet (AOS™) technique. A full insertion was achieved and confirmed with intraoperative X-ray. Neural response telemetry was completed.

How are things going for the patient?

At his one-year evaluation of the left cochlear implant surgery, this patient had an open set word score of than 94% in CI ear alone. There have been no issues with facial nerve stimulation. He continued to be bimodal (HA+CI) and deferred a sequential CI due to the pandemic. In October 2020, he went uncomplicated sequential RIGHT CI with a CI612. He is very happy with bilateral cochlear implants and performing well.

To hear more from Dr. Friedmann, listen to our Cochlear Case Studies surgeon panel webinar!

About the author:

David R Friedmann, MD, MSc is a neurotologist, cochlear implant surgeon and clinical investigator at NYU Grossman School of Medicine. His research interests include cochlear implants in unique populations including those with residual hearing, single-sided deafness and abnormal cochleae as well as cochlear implant electrode design. Dr. Friedmann is a nationally funded principal investigator studying the management of severe hearing loss.

Clinical Programming Series: Impedances

August 7, 2024
  • Approximately 5 minutes to read
  • Learning objectives:
    • Understand why and how impedances provide valuable clinical information
    • Understand what factors impact impedances
    • Understand how the clinician can use impedance measurements to determine the need for programming changes

Why are we talking about impedances?

As cochlear implant audiologists, the concept of impedances is integral to our clinical lexicon. Due to the growing interest in a more in-depth understanding of impedances, our clinical team has compiled a summary that delves into the science of impedances in cochlear implant care and outlines the essential information for programming cochlear implants.

What are impedances?

When electrical current flows in a conductor (in this case, the cochlea) there is a force that opposes the flow of the electrical current through the cochlea to the spiral ganglion cells.  This is known as resistance. All materials naturally contain some resistance to the flow of an electrical current. Electrode impedances measures this resistance to the flow of electrical current from the cochlear implant electrode to the spiral ganglion cells.

Electrical impedance is calculated as the ratio of the applied voltage (driving force) to the resulting current that flows through the material or solution.

How does Cochlear calculate impedances?

Cochlear calculates the total impedance which includes the Polarization Impedance and the Access Impedance. Polarization Impedance looks at the electrode-electrolyte interface. Polarization impedances are caused by electrochemical effects at the electrode’s electrode-fluid interface. Access Impedance looks at the bulk material around the electrode. High access impedances are caused by the presence of fibrous tissue or new bone growth around the electrode array. To have an accurate understanding of the surface quality change of the electrodes, it’s necessary to assess both Access and Polarization Impedances. Total impedance offers the most complete picture of impedance and its effect on compliance, power requirements, and MAP parameters.

Impedance in a tissue-stimulating system is more complex than a simple material or solution due to the dynamic behavior of the electrode-tissue interface.  Biological processes at a cellular level can change the electrode-tissue interface and therefore also affect the impedance of the system over time frames ranging from seconds to minutes to much longer periods.

Impedance measurements are included in Cochlear™ Nucleus® implants to perform three functions:

  • To confirm the integrity of the electrode contacts through detection of open and short circuits.
  • To ensure the map is set to maintain electrodes in compliance.
  • To provide some insight into the characteristics of the local environment around the electrode to assist with clinical management.

What factors can impact impedances?

Conditions unrelated to a patient’s hearing have been associated with changes in hearing outcomes or impedance.  In these cases, it may take an extended time for clinicians to find out that a recipient is on contributing drug therapy since the recipient may not associate other health conditions with challenges in their hearing. Papers have associated impedance rises to Meniere’s disease and tinnitus1, labyrinthitis2, otitis media3, 4, delayed hearing loss5, and episodes of vertigo2, 6. In these instances, the impedance change is an indicator of some process that is happening in the inner ear. 

There are reports involving bilateral recipients where impedances are seen to rise in a single ear1, and others where the process involves both ears2 suggesting a more systemic involvement. Interestingly one bilateral case with different model implants experienced increased impedance in both implants at the same time2.

A number of papers report on the potential for pharmaceuticals to reduce electrode impedance. In one case treatment with cortisone, antibiotics and widening pulse widths resulted in impedances falling over 25 kohm to under 14 kohm within 24 hours2. 

Why is it important to monitor impedances?

Alterations in impedance can lead to reduced performance in patients. By managing these changes through medical intervention or by adjusting the pulse width, these issues can be addressed, resulting in optimization of the recipient’s programming.

How do we use this information clinically?

Regular measurement of electrode impedances is considered good clinical practice, typically performed at each programming session. For adults and children capable of providing feedback on their cochlear implant’s sound quality, routine monitoring of the impedance profile, alongside speech perception measures and other case information, constitutes a best management approach. This practice establishes a historical record of impedance measurements, facilitating correlation with additional recipient data collected over time. Should any electrodes fall out of compliance, it is common practice to increase the pulse width across the array to return these channels to compliance, rather than deactivating.

Additionally, electrode impedance measurements detect circumstances under which certain electrodes should not be used, such as open or short circuits. Since each electrode interacts with its local environment, impedances can vary from electrode to electrode across the array.  An unexpected impedance pattern calls for a detailed review of the electrode impedance data in context with the recipient’s imaging, programming, medical history, and auditory performance.

Please reach out to your local Cochlear representative to learn more about what impedance measurements can tell you about your patient’s cochlear implant.

1 McNeill, A., & Eykamp, K. (2016). Cochlear Implant Impedance Fluctuation in Meniere’s Disease: A Case Study. Otology & Neurotology, 37(7), 873-877.

2 Neuburger, J., Lenarz, T., Lesinski-Schiedat, A., &  Büchner, A. (2009). Spontaneous increases in impedance following cochlear implantation: Suspected causes and management. International Journal of Audiology, 48(5), 233-239.

3 Vargas, J.L., Sainz, M., Roldan, C., Alvarez, I., & Torre, A. (2012) Long-tern evolution of the electrical stimulation levels for cochlear implant patients. Clinical and Experimental Otorhinolaryngology, 5(4), 194-200.

4 Dixon, J.F., Shinn, J.B., Adkins, M., Hardin, B.D., & Bush, M.L. (2015). Middle Ear Disease and Cochlear Implant Function: A Case Study. Hearing Balance and Communication, 12, 155-158.

5 Scheperle, R.A., Tejani, V.D., Omtvedt, J.K., Brown, C.J., Abbas, P.J., Hansen, M.R., Gantz, B.J, Oleson, J.J, & Ozanne, M.V. (2017). Delayed changes in auditory status in cochlear implant users with preserved acoustic hearing. Hearing Research, 350, 45-57.

6 Plontke, S.K., Götze, G., Rahne, T., & Liebau, A. (2017). Intracochlear drug delivery in combination with cochlear implants. HNO, 65, 19-28.

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This material is intended for health professionals. If you are a consumer, 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.

 

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