Out of Committee: The Cochlear Implant: Past, Present, and Future of a Game-Changing Device
From the Drugs and Devices Committees The development and use of the cochlear implant has been one the most significant advances in otolaryngology in the last century. It has truly revolutionized what we as otolaryngologists can offer to our patients with the most significant cases of hearing loss. While this “game-changing” medical device now stands in the limelight, its conception and early development was met with much resistance from recognized leaders in our field and great opposition from the deaf community, which considered it “genocide” to their culture. The early work of Volta, Djourno, Eyries, and others eventually led William House to successfully implant a single electrode device into the cochlea of a human patient in 1961. Shortly thereafter, Blair Simmons and Robin Michelson placed multichannel implants. Subsequently, decades of dedication by surgeons, scientists, audiologists, and speech pathologists have enabled countless deaf children and adults to hear. Current implants allow recipients to gain sufficient open set speech to talk on a telephone, be mainstreamed to enter schools with hearing children, and use speech to function and communicate well in various professional and social settings. Studies have shown that many implant users perform at or near the level of normally hearing peers on certain speech testing batteries. The magnitude of these achievements is reflected in the awarding of the prestigious Lasker-DeBakey Clinical Medical Research Award to Graeme Clark, Ingeborg Hochmair, and Blake Wilson in 2013 for their efforts in the development of cochlear implants. Despite these successes and numerous studies that have shown that cochlear implants are both clinically and cost effective, the overall utilization rate of this device in the United States is estimated at an astoundingly low 6 percent. Specifically for children in the U.S., the utilization rate is a much more favorable 50 percent of those who would qualify based on their audiological profile, largely due to the positive effects of the implementation of Universal Newborn Hearing Screening in 1999. Nevertheless, this still fails to compare to the 90 percent utilization rates in certain areas in Europe. Several factors may be contributing to this low utilization rate. The first is that there is a low general awareness of cochlear implants and their potential benefits by both the public as well as primary care physicians. This poor understanding of candidacy and outcomes by referring providers may be a critical hurdle in getting the majority of patients who could benefit from an implant into the office of an otolaryngologist who can offer services. In addition, while there have been some positive changes from the early days of cochlear implantation, political resistance from organizations such as the deaf community, National Association of the Deaf, and the Autism Free America groups continue to exist. Lastly, financial issues limiting hospitals and clinics continue to play a major role. With the metric of “quality of care” being on the forefront of healthcare governing bodies, hospital administrators, and the public, the development of widely accepted “best clinical practice” guidelines may provide a means to improve our ability to reach a greater proportion of the patients who could benefit from a cochlear implant. With the focused efforts of groups such as the recently incorporated American Cochlear Implant Alliance, we stand stronger to make progress on this front. Despite these challenges, the number of patients receiving cochlear implants continues to grow and indications for surgery are further expanding. Initially a therapy offered only to adults with bilateral profound hearing loss, later it was approved for children two years and older in 1990 by the FDA. Today, children 12 months, and even younger in some cases, are gaining hearing with surgery. In addition to the lower limits of age, the increasing benefits of surgery outweighing the risks have permitted the audiological criteria for candidacy to evolve allowing for patients with less severe levels of hearing loss to qualify for implantation. While the standard adult candidate is someone who is considered to have little or no benefit from hearing aids based on speech recognition testing with scores of less than 50 percent on the ear to be implanted and less than 60 percent in the non-implanted ear or in the binaural condition, there has been much research demonstrating the benefits of cochlear implantation in patients with residual low frequency hearing. Hearing preservation techniques and hybrid implants providing electrical and acoustic stimulation have been used for years in Europe. These devices are currently in the final stages of approval by the Food and Drug Administration. This would provide individuals in the United States with high frequency sensorineural or “ski slope” hearing loss the opportunity to improve their communication function with a cochlear implant. In addition, currently there is much investigation in the areas of cochlear implantation for single-sided deafness and a therapy for tinnitus that may soon further expand the use of this innovative medical device. Future technologies are aimed at enhancing sound quality, improving safety and reliability, and reducing costs. Incorporating technologies such as drug-eluting electrode arrays to reduce trauma from surgery, repairing damaged tissue biologically with stem cells, and developing new, more effective materials may provide avenues to bring the function of cochlear implants to the next level. With these ongoing efforts, we likely do not yet know the limits yet of this game-changing device.
From the Drugs and Devices Committees
The development and use of the cochlear implant has been one the most significant advances in otolaryngology in the last century. It has truly revolutionized what we as otolaryngologists can offer to our patients with the most significant cases of hearing loss. While this “game-changing” medical device now stands in the limelight, its conception and early development was met with much resistance from recognized leaders in our field and great opposition from the deaf community, which considered it “genocide” to their culture.
The early work of Volta, Djourno, Eyries, and others eventually led William House to successfully implant a single electrode device into the cochlea of a human patient in 1961. Shortly thereafter, Blair Simmons and Robin Michelson placed multichannel implants. Subsequently, decades of dedication by surgeons, scientists, audiologists, and speech pathologists have enabled countless deaf children and adults to hear. Current implants allow recipients to gain sufficient open set speech to talk on a telephone, be mainstreamed to enter schools with hearing children, and use speech to function and communicate well in various professional and social settings. Studies have shown that many implant users perform at or near the level of normally hearing peers on certain speech testing batteries. The magnitude of these achievements is reflected in the awarding of the prestigious Lasker-DeBakey Clinical Medical Research Award to Graeme Clark, Ingeborg Hochmair, and Blake Wilson in 2013 for their efforts in the development of cochlear implants.
Despite these successes and numerous studies that have shown that cochlear implants are both clinically and cost effective, the overall utilization rate of this device in the United States is estimated at an astoundingly low 6 percent. Specifically for children in the U.S., the utilization rate is a much more favorable 50 percent of those who would qualify based on their audiological profile, largely due to the positive effects of the implementation of Universal Newborn Hearing Screening in 1999. Nevertheless, this still fails to compare to the 90 percent utilization rates in certain areas in Europe.
Several factors may be contributing to this low utilization rate. The first is that there is a low general awareness of cochlear implants and their potential benefits by both the public as well as primary care physicians. This poor understanding of candidacy and outcomes by referring providers may be a critical hurdle in getting the majority of patients who could benefit from an implant into the office of an otolaryngologist who can offer services. In addition, while there have been some positive changes from the early days of cochlear implantation, political resistance from organizations such as the deaf community, National Association of the Deaf, and the Autism Free America groups continue to exist.
Lastly, financial issues limiting hospitals and clinics continue to play a major role. With the metric of “quality of care” being on the forefront of healthcare governing bodies, hospital administrators, and the public, the development of widely accepted “best clinical practice” guidelines may provide a means to improve our ability to reach a greater proportion of the patients who could benefit from a cochlear implant. With the focused efforts of groups such as the recently incorporated American Cochlear Implant Alliance, we stand stronger to make progress on this front.
Despite these challenges, the number of patients receiving cochlear implants continues to grow and indications for surgery are further expanding. Initially a therapy offered only to adults with bilateral profound hearing loss, later it was approved for children two years and older in 1990 by the FDA. Today, children 12 months, and even younger in some cases, are gaining hearing with surgery. In addition to the lower limits of age, the increasing benefits of surgery outweighing the risks have permitted the audiological criteria for candidacy to evolve allowing for patients with less severe levels of hearing loss to qualify for implantation. While the standard adult candidate is someone who is considered to have little or no benefit from hearing aids based on speech recognition testing with scores of less than 50 percent on the ear to be implanted and less than 60 percent in the non-implanted ear or in the binaural condition, there has been much research demonstrating the benefits of cochlear implantation in patients with residual low frequency hearing. Hearing preservation techniques and hybrid implants providing electrical and acoustic stimulation have been used for years in Europe. These devices are currently in the final stages of approval by the Food and Drug Administration. This would provide individuals in the United States with high frequency sensorineural or “ski slope” hearing loss the opportunity to improve their communication function with a cochlear implant. In addition, currently there is much investigation in the areas of cochlear implantation for single-sided deafness and a therapy for tinnitus that may soon further expand the use of this innovative medical device.
Future technologies are aimed at enhancing sound quality, improving safety and reliability, and reducing costs. Incorporating technologies such as drug-eluting electrode arrays to reduce trauma from surgery, repairing damaged tissue biologically with stem cells, and developing new, more effective materials may provide avenues to bring the function of cochlear implants to the next level. With these ongoing efforts, we likely do not yet know the limits yet of this game-changing device.