cochlear implant surgery fda

In Survey, 78% of Cochlear Implant Surgeons Indicate they are Conducting Implantation Outside of Current FDA Labeling

A recently published study suggests that US physicians are performing cochlear implantation for a number of conditions that are considered “off-label” of the current FDA labeling indications for implantation.

The existing FDA indications for cochlear implantation, as pointed out in an article on the study in ENT Today, date back nearly two decades and cover implantation guidelines for adults and children who have severe hearing loss and do not benefit from conventional hearing aids.

 

Study Results Suggest Cochlear Implant Guidelines May Need Update

 

The study, led by Dr. Matthew Carlson, an associate professor of otolaryngology and medical director of the cochlear implant program at the Mayo Clinic, found many physicians using cochlear implants for patients with varying degrees of hearing loss in one or both ears.

Researchers anonymously surveyed 81 members of the American Neurotology Society who regularly performed cochlear implantation.

 

A total of 78% of respondents of the survey performed cochlear implantation for at least one of the following indications within the last 2 years: profound hearing loss in children less than 12 months of age (43%), children with asymmetrical hearing loss where at least one ear was better than performance cutoff for age (31%), adults with asymmetrical hearing where at least one ear was better than the performance cutoff for adult criteria (61%), single-sided deafness (46%), and ipsilateral vestibular schwannoma (35%).

 

The survey also found that clinics with a higher volume of implantations being conducted were more likely to have performed off-label surgeries.

Researchers also surveyed respondents regarding their speech perception testing practices for adult candidacy assessment:

  • Use of AzBio sentences: 100%
  • Use of CNC word scores: 56%
  • Use of HINT testing: 35%
  • Use of BKB-SIN testing: 9%
  • Use of CUNY scores: 8%

A large majority of survey respondents reported routine use of speech-in-noise tests to determine adult cochlear implant candidacy, with 28% reporting selective use only when patient scores were borderline in quiet, and 4% reported that their center does not currently use speech-in-noise testing for candidacy determination.

 

“It’s valuable to evaluate and understand your practice in the context of the greater surgical community. We all want to be sure we are on the cutting edge of care in order to maximize outcomes for our patients. Our surgical techniques have become increasingly refined and the devices have undergone substantiation innovation over the last several decades, however we are still stuck with the older guidelines,” –Dr. Matthew Carlson, in comments to ENT Today

 

The researchers hope that current FDA labeling will eventually expand to provide a better reflection of today’s clinical landscape.

 

 


2 Comments

  1. The burden of rehabilitation and outcomes rests on the audiologist. The surgery itself has its own physiologic limitations and CI surgeons may see some factors beyond their control.

  2. FDA regulations are usually way behind technology changes. The government takes a long time to understand, assimilate and arrive at conclusions before regulations are put in place.

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