University of Iowa resumes CI operations and implants world’s first Cochlear™ Nucleus® Profile™ Plus with Slim 20 Electrode

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By Wade Colburn, Product Manager – Cochlear Implants

Early in the COVID-19 crisis, widespread uncertainty led to clinic visits and surgeries being postponed or cancelled until further notice.  While the situation continues to evolve, some clinics are starting again to schedule patients and surgeries. However, the approach will continue to vary across the country based largely on the number of patients being treated for COVID-19 at the facility and the response by local government and/or hospital systems.  

The University of Iowa is one clinic that is carefully starting to establish a ‘new normal’. Following a reduction of clinic efficiency down to approximately 10% in April, the clinic and operating room are now working at about 70-80% efficiency after resuming operations at the direction of the Governor and University of Iowa administration. Now, clinic appointments and surgeries are once again underway, but only with very detailed precautions.  Camille Dunn, PhD, and Bruce Gantz, MD recently spoke with Cochlear to share some of those precautions and their experiences as they resume patient care.  Dr. Dunn explains, “We have instilled both a mixture of facility-wide precautions and clinic-specific considerations.  Some of these precautions include calling patients ahead of the clinic visit to conduct a verbal COVID-19 screen, wearing masks and shields during and between appointments, and staggering patient schedules to facilitate enhanced cleaning measures and reduce the number of patients in a waiting room.”

As far as the operating room, Dr. Gantz, who serves as the Chair of the Surgical Services Committee that oversees the Operating Room Guidelines, mentions he “feels safer at the hospital than the grocery store,” considering the precautions implemented to minimize risk to patients and staff.  Such precautions include COVID-19 testing 24-hours prior to surgery, with a requirement to sequester overnight.  Further, specific guidelines on who may accompany a patient to their clinic visit or surgery have been put into place, and all faculty and staff can be found wearing masks and face shields. 

When asked about his belief on whether hearing procedures should be considered medically necessary, Dr. Gantz says, “We don’t do surgeries unless they are medically necessary, so yes. Here in Iowa, we don’t have a large number of COVID-19 patients in the hospital, so we feel confident doing these procedures with the appropriate precautions in place.” He also mentions the outpatient aspect of the surgery minimizes impact to the hospital system overall.

On May 1st, Dr. Gantz and the University of Iowa team resumed cochlear implant surgeries.  The first surgery performed used a Cochlear™ Nucleus® Profile™ Plus with Slim 20 Electrode (CI624) – the first surgery in the world utilizing Cochlear’s newest electrode.  The Slim 20 Electrode expands Cochlear’s portfolio which consists of the slimmest electrodes, designed to be atraumatic, on the market, providing an option for surgeons who prefer an insertion depth of up to 20mm with a lateral wall electrode.1 Specifically, Slim 20 was designed with a basal support, optimized for insertion to 20 mm, to assist in the preservation of apical structures within the cochlea.2,3,4

Slim 20, currently under evaluation in a controlled market release until late summer, received FDA approval in February.  When asked about his inaugural experience with the electrode, Gantz says, “I liked the electrode. It handled well and we were able to insert to 20 mm without much of an unintended shift in the low frequencies immediately post-op.” With promising real time measures and outcomes from the first patient indicating preservation of apical structures, the University of Iowa and Cochlear will look to continue to partner to study this new array.

Iowa is just one of many centers that are resuming patient operations. And while the visits may look a bit different, clinicians are still committed to delivering the same level of overall care. Dr. Dunn explains that “some patients don’t want to come in until the pandemic calms down, but many are reassured when we explain the precautions we are taking to ensure patient and staff safety.”  In the near-term, University of Iowa will focus on addressing the backlog of patients whose appointments were postponed during the stay-home period, as well as other high priority patients.  However, they will also continue to perform evaluations and routine clinic check-ins.  For patients who are still reticent or unable to come into the clinic, Dr. Dunn says they will consider using Remote Check, which was recently approved by FDA and is also in a controlled market release.  “Remote Check enables us to connect with our patients and confirm that they are still performing well.  We can bring them back in as needed when things settle down,” says Dr. Dunn. While this represents the singular experience of the University of Iowa, Cochlear recognizes that how other institutions and clinics resume operations will vary across the country.  Wherever your center is located or where it is in the recovery process, Cochlear has tools and resources to help navigate this new patient care paradigm. 

Learn more here!

About our guest author: Wade Colburn is the Product Manager, Cochlear Implants at Cochlear Americas. Wade is responsible for managing product lifecycle and providing technical support to customers.  Wade is a biomedical engineer from North Carolina State University with extensive experience within otology prior to joining Cochlear.

References

1. FUN1142: Electrode Comparison Chart

2. D1631690: EA24 Temporal Bone Insertion Safety Study Report.

3. D1609086: CI624 Physician’s Guide.

4. FUN3844: Technical Specification for CI624

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