Cochlear Implant Soft Failures Consensus Development Conference Statement

Abstract

The statement is based on 1) preliminary research and consultation by a steering committee selected for their relevant experience representing the professions of individuals working with cochlear implants; 2) presentations by representatives of this working group on issues relevant to the consensus questions during an open session at the Consensus Conference on Cochlear Implant Soft Failures held in conjunction with the 10 th Symposium on Cochlear Implantation in Children (Dallas, Texas, March 15-19, 2005); 3) closed deliberations by members of the steering committee; and 4) input from attendees during the open session of the Consensus Conference. This statement is an independent report and is not a policy statement of any organization.The statement reflects the panel's assessment of relevant information available at the time it was written. It is to be expected that new information and data constantly are being generated that may alter the recommendations of this panel. The list of references accompanying this report includes the primary sources used by the panelists in developing their preliminary statements (1-19). OBJECTIVESTo provide professionals working in all areas of cochlear implantation with a current consensus on the terminology, definition, diagnosis, and management of suspected cochlear implant malfunctions widely referred to as soft failures. PARTICIPANTSThe panels consisted of 18 individuals directly involved in development, manufacturing, and clinical application of cochlear implants. Representatives from the specialties of otolaryngology, audiology, bioengineering, speech and language pathology, communication sciences, and industry participated. Interactive presentations were made during an open session in the Consensus Conference to an audience of approximately 190 professionals.

Foreign Body or Hypersensitivity Granuloma of the Inner Ear After Cochlear Implantation: One Possible Cause of a Soft Failure?

“…Delayed failure of cochlear implantation may be ascribed to a device failure, either 1) failure to lock or 2) failure to otherwise meet manufacturer’s specifications, described as a “hard failure” or may be due to a performance decrement unexplained by integrity testing (“soft failure”) (Buchman et al 2004, Balkany et al 2005, European Concensus statement 2005, Cote et al 2007). There are very little data on the success rate of reversing the decrement in auditory function by reimplantation in soft failures, although Buchman et al (2004) suggest that auditory symptoms were resolved in 87% of such patients.…”

“…The European consensus statement on cochlear implant failures (2005) categorized device failures as (1) those cases in which the electrical characteristics of the cochlear implant were outside the manufacturer’s specifications, resulting in loss of clinical benefit (nearly equivalent to the definition of hard failures (Buchman et al 2004) and (2) those with performance decrements unexplained based on manufacturers specifications. The cochlear implant soft failures consensus development conference (Balkany et al 2005) defined a soft failure as a suspected but not proven device malfunction. The characteristic symptoms in such patients included shocking sensations, popping sounds, intermittency or an unexplained progressive decrement in performance.…”

Medical and bioethical considerations in elective cochlear implant array removal

“…In instances where the cochlea on the implanted side is no longer a viable option for reimplantation, the contralateral side can be used. This procedure, however, has its own complications, as the duration and degree of hearing loss may suggest that this ear may have different outcomes than the previously implanted side 5. Removal of the failed device and implantation of the contralateral side also exposes the patient to additional surgeries and precludes them from being reimplanted on the original side in the future 5.…”

“…This procedure, however, has its own complications, as the duration and degree of hearing loss may suggest that this ear may have different outcomes than the previously implanted side 5. Removal of the failed device and implantation of the contralateral side also exposes the patient to additional surgeries and precludes them from being reimplanted on the original side in the future 5. Another scenario to consider is that in many countries, including USA, bilateral cochlear implantation is becoming more common.…”

Detecting Soft Failures in Pediatric Cochlear Implants

“…Cochlear implant (CI) “soft” failure is a working diagnosis that is supported by clinical, audiologic, and radiographic criteria (1–2). Typically, patients present with a deterioration in their previous implant performance, a failure to progress in language development, or new symptoms such as facial nerve stimulation or pain with use of the implant.…”