Expanded Cochlear Implant Candidacy Recent technological advancements that integrate CIs with hearing aids have widened the pool of candidates for implantation. All Ears on Audiology
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All Ears on Audiology  |   March 01, 2017
Expanded Cochlear Implant Candidacy
Author Notes
  • Teresa A. Zwolan, PhD, CCC-A, is a professor in the Department of Otolaryngology-Head & Neck Surgery and director of the Cochlear Implant Program at the University of Michigan. zwolan@med.umich.edu
    Teresa A. Zwolan, PhD, CCC-A, is a professor in the Department of Otolaryngology-Head & Neck Surgery and director of the Cochlear Implant Program at the University of Michigan. zwolan@med.umich.edu×
  • Donna L. Sorkin, MA, is the executive director of the American Cochlear Implant Alliance. dsorkin@acialliance.org
    Donna L. Sorkin, MA, is the executive director of the American Cochlear Implant Alliance. dsorkin@acialliance.org×
Article Information
Hearing Aids, Cochlear Implants & Assistive Technology / All Ears on Audiology
All Ears on Audiology   |   March 01, 2017
Expanded Cochlear Implant Candidacy
The ASHA Leader, March 2017, Vol. 22, 14-15. doi:10.1044/leader.AEA.22032017.14
The ASHA Leader, March 2017, Vol. 22, 14-15. doi:10.1044/leader.AEA.22032017.14
Hearing aids and cochlear implants (CIs) are no longer separate, distinct and mutually exclusive technologies. Recent developments in research and technology have expanded the candidate population and blurred the lines between the two types of devices.
Studies have shown that combining hearing aids and CIs can result in greatly improved outcomes, bringing people closer to normal hearing. Technologies that combine these devices use improved sound-processing strategies; new electrode configurations with improved surgical techniques that increase the likelihood of hearing preservation; sleek processor designs; and Bluetooth, streaming and telecoil to enhance usability and performance in background noise.
By taking these innovations into consideration, audiologists may well find that a wider swath of patients could be appropriate candidates for CIs.
Electro-acoustic advances
Recent FDA approval of two electro-acoustic (EA) CI systems designed to retain residual hearing in low frequencies has widened CI candidacy criteria. The Cochlear Hybrid and the MED-EL EAS systems are approved for patients whose hearing loss ranges from normal to moderate in the low frequencies and severe to profound in the mid to high frequencies.
For the Cochlear Hybrid, the candidate’s monosyllabic word scores should fall between 10 and 60 percent correct in the ear to be implanted and can be as high as 80 percent correct in the contralateral ear. For the MED-EL EAS, monosyllabic word scores should be less than or equal to 60 percent correct in the patient’s best-aided condition.
These criteria represent a dramatic change from early FDA candidacy guidelines, which specified that patients should present with bilateral profound sensorineural hearing loss with little or no speech recognition on sentence tests. The new standards use monosyllabic word tests instead, which are typically more difficult than sentence tests. Therefore, some EA candidates demonstrate sentence recognition scores in excess of 80 percent correct.
Both of these EA devices received FDA approval following complex clinical trials that demonstrated their effectiveness in patients with greater preoperative residual hearing and better speech-recognition skills. Both studies documented hearing preservation for a majority of participants, and users of both devices experienced improved performance post-operatively with electro-acoustic stimulation compared with preoperative performance with hearing aids.

FDA approval of two electro-acoustic devices has increased awareness of benefits of cochlear implantation for a larger population, including those who may benefit from bimodal hearing.

Expanding CI candidacy
FDA approval of the two EA devices has increased awareness of benefits of cochlear implantation for a larger population, including those who may benefit from bimodal hearing—use of a CI on one ear and a traditional hearing aid on the other.
In some instances, CI criteria are based on best-aided performance, meaning that a patient may not qualify for a CI even if one ear is profound, as the better-hearing ear may cause their scores to be “too good” in the best-aided condition. Today, some clinicians may seek preauthorization to implant the poorer ear, expecting postoperative improvement with bimodal hearing.
Another reason to support such a recommendation is the realization that waiting for hearing in the better ear to drop may take years, which would deprive the patient of access to quality sound and may preclude a good outcome if the long-deafened ear is selected for implantation several years later.
Other trends in the field include the use of more difficult test materials, such as presenting words or sentences in the presence of background noise, which makes them more reflective of real-world listening challenges. Additionally, we’ve seen an increase in nontraditional candidates who receive CIs—such as children and adults with single-sided deafness and children with multiple disabilities. We also see use of auditory brainstem implants in children with severe cochlear malformations that prevent them from benefitting from a traditional CI.

Audiologists and speech-language pathologists play a key role in referring patients for CI candidacy evaluation.

Expanding Medicare criteria
The Centers for Medicare and Medicaid Services (CMS) has also recognized the potential benefit of providing CIs to people with more hearing. For years, Medicare has covered CIs only for candidates who presented with a bilateral moderate-to-profound hearing loss and demonstrated sentence-recognition scores of less than 40 percent in the best-aided condition.
In 2013, the American Cochlear Implant Alliance proposed—and CMS approved—a Coverage with Evidence Development (CED) study. This study, now underway in 20 centers throughout the country, is evaluating CI performance of adults with bilateral moderate-to-profound hearing loss with pre-CI scores of 40 to 60 percent correct on sentences in the best-aided condition.
The participating CED centers can provide CIs to patients who meet the study criteria. On completion of the study, CMS will consider possible expansion of its national coverage determinations.
Audiologists and speech-language pathologists play a key role in referring patients for CI candidacy evaluation. We recommend contacting your local CI clinic when considering a patient referral. These discussions can provide valuable insight about technology advances, changes in candidacy criteria, and research projects that may provide opportunities for nontraditional candidates to receive a CI.
Looking ahead, more people will wear devices that combine electric and acoustic technologies, and further expansion in CI candidacy is likely. Among the greatest challenges will be raising awareness of the benefits of the technology and bolstering interprofessional collaboration to boost access to care for all who need it.
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March 2017
Volume 22, Issue 3