YORK (Reuters Health) – Cochlear implantation is commonly performed for indications beyond those included in device labeling, according to a survey of American Neurotology Society (ANS) members.
Label indications for cochlear implantation were issued more than 17 years ago. They include:
– adults who score 50% or lower in the ear to be implanted, and 60% or lower in the best-aided listening condition, on recorded open set sentence recognition; and
– children at least 12 months old with bilateral profound sensorineural hearing loss (SNHL) who gain limited benefits from appropriately fitted hearing aids.
Many practitioners find these candidacy guidelines to be too restrictive, and increasing numbers of centers perform cochlear implantation for off-label or nontraditional indications.
To examine practice variation in cochlear implant candidacy assessment and off-label indications, Dr. Matthew L. Carlson from Mayo Clinic School of Medicine, Rochester, Minnesota, and colleagues distributed a 26-item web-based survey to 627 ANS members, 81 of whom completed and returned them.
The findings were published online January 1 in Otology and Neurotology.
More than three-quarters of respondents (78%) reported performing cochlear implantation for at least one of the following off-label and/or nontraditional indications within the past 2 years:
– profound hearing loss in children younger than 12 months (43%);
– children with asymmetrical hearing loss where at least one ear scored better than performance cutoff for age (31%);
– adults with asymmetrical hearing loss where at least one ear scored better than performance cutoff for adult criteria (60%);
– single-sided deafness (46%); and
– ipsilateral vestibular schwannoma (35%).
According to the survey results, the areas most likely to provide the greatest immediate opportunity for program growth would be FDA approval of cochlear implantation for single-sided deafness (44%), FDA approval for implantation in patients with greater degrees of residual hearing (27%), and greater access to patients who meet existing/current candidacy criteria (29%).
In evaluating candidacy for cochlear implantation, 100% of respondents routinely used AzBio sentences, 56% used consonant-nucleus-consonant word scores, and 35% used a hearing in noise test (HINT).
Overall, 19% of respondents performed only unilateral implantation in the Medicare population and 28% considered bilateral implantation in the second ear only if both the implanted and hearing aid ears score below the candidacy cutoff, whereas 53% considered implantation of the second ear without regard to performance of the implanted ear.
“The high percentage of surgeons performing implantations for off-label or nontraditional indications reflects the overly restrictive and dated status of current implant guidelines,” the researchers conclude. “With greater adoption of more difficult speech perception testing in noise, careful clinical judgment is needed to maintain a favorable risk-benefit balance for prospective implant candidates.”
Dr. P.J. Govaerts from The Ear Group, Antwerp-Deurne, Belgium, who has previously argued that cochlear implantation selection criteria are out-of-date and should be abandoned, told Reuters Health by email, “Even 30 years after the introduction of this new medical option/technique, huge variation exists between different cochlear implantation (CI) centers in the U.S., and even more when considering global practice. This holds for the audiological tests used to select and evaluate candidates, as well as for the ultimate indications.”
“There is no consensus on GCP (good clinical practice),” he said. “Although this cannot be avoided for emerging treatments, it means that the choices patients get offered really depend on the center they visit and the knowledge available in that center. The fact that so many specialists go off-label indicates that the regulatory bodies are too conservative and fail to follow the pace of the real world. A consequence is that many patients are refused access to” available treatments that the specialists consider beneficial.
“Medicine remains an art,” Dr. Govaerts said. “It is the duty of a medical professional to analyze his/her own results and to offer treatments that will improve the patient’s outcome, not based on literature statistics, but based on his/her own individual statistics. This justifies some differences between centers/clinicians, and the world should live with it.”
“At the same time, excellence should remain the driving force, and regulatory bodies should base their restrictions, if any, on recommendations by excellent experts rather than on democratic consensus,” he said. “This is essential to keep space for progress.”
Dr. Carlson was unavailable for comment.
SOURCE: http://bit.ly/2EMLgO5
Otol Neurotol 2018.
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