Cochlear Implants
by Jamie Schwartz

Cochlear™ Nucleus® implant candidacy and indications for adult and pediatric patients

August 29, 2018
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Cochlear™ Nucleus® implant (CI) candidacy and indications are important when counseling both adult and pediatric patients. In adults, cochlear implants can significantly improve hearing performance and quality of life.1 This can have a positive effect on the patients’ overall physical and mental health as well by reducing anxiety and stress.2

For pediatric patients, a cochlear implant is vital to giving children access to sound for proper speech and language development.3

Below you will find U.S. FDA indications regarding Nucleus cochlear implant candidacy for both adults and children. As well as Nucleus Hybrid™ System* candidacy.

Adult CI Candidacy4

For those over the age of 18 the criteria include:

Those who have bilateral, pre, peri or postlinguistic sensorineural hearing impairment.

Those with a moderate to profound hearing loss in the low frequencies and profound (≥90 dB HL) hearing loss in the mid to high speech frequencies. Also,the candidate must obtain limited benefit from appropriate hearing aids. Limited benefit from amplification is defined by test scores of 50% correct or less in the ear to be implanted (60% or less in the best-aided listening condition) on recorded tests of open set sentence recognition.

Adult Hybrid Candidacy

The Cochlear Nucleus® Hybrid System is made up of the Nucleus Hybrid L24 implant and the Nucleus sound processor combining acoustic amplification for the low frequencies with electric stimulation for the high frequencies. The Nucleus Hybrid System is indicated for unilateral use in patients age 18 years and older who have residual low frequency hearing sensitivity and severe to profound high-frequency sensorineural hearing loss, and who obtain limited benefit from appropriately fitted bilateral hearing aids.

Candidates range from normal to moderate hearing loss in the low frequencies (thresholds better than 60 dB HL up to and including 500 Hz). Severe to profound mid to high-frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted.

The CNC word recognition score for the ear to be implanted must be between 10% and 60%, inclusively, in the ear to be implanted in the preoperative aided condition. The contralateral ear’s CNC score criteria are equal to or better than that of the ear to be implanted, but not better than 80% correct. Moderately severe to profound mid- to high frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥ 60 dB HL) in the contralateral ear.

CI and Hybrid candidacy graphs

Pediatric CI Candidacy4

The cochlear implant system for those 12 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids.

Children 2 years of age or older may demonstrate severe to profound hearing loss bilaterally.

In younger children, limited benefit is defined as lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and participation in intensive aural habilitation over a three to six month period. It is recommended that limited benefit be quantified on a measure such as the Meaningful Auditory Integration Scale or the Early Speech Perception test.

In older children, limited benefit is defined as ≤ 30% correct on the open set Multisyllabic Lexical Neighborhood Test (MLNT) or Lexical Neighborhood Test (LNT), depending upon the child’s cognitive and linguistic skills. A three to six month hearing aid trial is recommended for children without previous aided experience.

CI Contraindications4

A Cochlear Nucleus cochlear implant is not suitable for individuals with the following conditions:

  • Deafness due to lesions of the acoustic nerve or central auditory pathway
  • Active middle ear infections
  • Absence of cochlear development
  • Tympanic membrane perforation in the presence of active middle ear disease

Visit our website for more information regarding cochlear implant candidacy and Hybrid candidacy.

References:
  1. Gaylor, BA. Raman, G. Chung, M. Cochlear Implantation in Adults. JAMA Otolaryngol Head Neck Surg. 2013 Mar;139(3):265-72.
  2. Manrique-Huarte R et al (2016) Treatment for hearing loss among the elderly: Auditory outcomes and impact on quality of life. Audiol Neurootol, 21 Suppl 1:29-35
  3. Novak MA, Firszt JB, Rotz LA, et al. Cochlear implants in infants and toddlers. Ann Otol Rhino Laryngol Suppl 2000;185:46-49
  4. Cochlear™ Nucleus® CI532 cochlear implant with Slim Modiolar electrode Physician’s Guide. March 2016.
* The Acoustic Component should only be used when behavioral audiometric thresholds can be obtained and the recipient can provide feedback regarding sound quality.
**The Hybrid L24 Implant is approved in the US for adults ages 18 and older.
Author

Jamie Schwartz

Jamie is the Associate Marketing Manager in the Product and Professional Marketing Department at Cochlear Americas. Jamie is responsible for ProNews blog content as well as professional social posts and calendars. If you are interested in being a guest author for the ProNews blog please contact Jamie by email at jschwartz@cochlear.com.

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Here are three Journal Club articles to bookmark:

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2. Pediatric Cochlear Implant Wear Time and Early Language Development

This Journal Club edition explores a study by the team at the University of North Carolina published in September 2019, Pediatric Cochlear Implant Wear Time and Early Language Development. The results of this study support the importance of consistent device use for language development in children and highlight device datalogging as a critical tool in measuring progress. The findings may also encourage professionals to consider how they counsel parents of young children who are using cochlear implants. 

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Survey reveals hearing loss can significantly affect relationships and families in the U.S.

May 1, 2019

Research updates

State of Hearing Report highlights the physical, emotional and societal challenges of hearing loss

Centennial, Colo. (May 1, 2019) — Three in four U.S. adults aged 65 years and older believe hearing loss is unavoidable and an inevitable part of aging, according to a new global report released to recognize Better Hearing and Speech Month in May.

The State of Hearing Report also highlights how hearing loss can affect a person’s day-to-day-life, self-esteem and ability to communicate as their families feel the strain. In the U.S., 57 percent of respondents said it could cause social isolation and 86 percent said it could affect relationships.

Sponsored by Cochlear, the global leader in implantable hearing solutions, the State of Hearing Report was a global survey to evaluate the challenges faced by people with hearing loss. Respondents in the U.S. included 1,269 adults, including 208 people aged 60 years and older. Notably, nearly 60 percent of people in the U.S. report having a close family member who has moderate to profound hearing loss, with more than one in three of those respondents stating that the hearing loss has had some level of impact on their communication.

“Results from the State of Hearing Report echo what physicians and advocacy groups who support those with hearing loss have known for many years – that hearing loss can have a profound impact on an individual’s personal, family and even professional life,” said Barbara Kelley, Executive Director, Hearing Loss Association of America. “These findings shine a spotlight on the serious need for additional education for the 48 million Americans who have some degree of hearing loss, but are unaware of options that will address their hearing loss and allow them to better function in their day-to-day lives.”

Despite 95 percent of U.S. respondents recognizing that the ability to hear is important for overall quality of life, only 41 percent have had a hearing test in the last two years, the report reveals. Among U.S. respondents over the age of 65 years, 87 percent said they knew where to get their hearing tested, but only 50 percent had acted to do so.

“As a practicing cochlear implant surgeon, I see first-hand both the burden debilitating hearing loss can have on a person and their family, but also the apathy with which they manage it,” said Brian Kaplan, M.D., Chairman, Department of Otolaryngology and Director, Cochlear Implant Program, Greater Baltimore (Md.) Medical Center, and Cochlear Medical Advisor. “There are millions of people in the U.S. who could benefit from the use of a hearing device, such as a cochlear implant or hearing aid, and I hope that more education around the true effect of hearing loss will drive patients and providers to seek proper diagnostic testing and treatment.”

Hearing loss is a significant public health issue in the U.S. and around the globe. According to the World Health Organization (WHO), hearing loss affects 466 million people worldwide,1 and one in three people over the age of 65 live with severe to profound forms of the condition.1 WHO figures also predict the total number of people living with hearing loss will nearly double by 2050, and this increase will be most noticeable amongst older people.1 Moreover, as the prevalence rates rise, the global cost of unaddressed hearing loss has been estimated at $750 billion per year.1

“At Cochlear, we are driven by our mission to improve the lives of people with hearing loss. There is increasing evidence of the importance of hearing to overall health, especially as people age,” said Patricia Trautwein, AuD, Vice President, Marketing and Product Management, Cochlear Americas. “With almost a quarter of people 65 to 74 years of age suffering disabling hearing loss, it is more important than ever to understand the impact of untreated hearing loss on people’s health, our communities and the economy to ensure people turn to treatment sooner.”

The research of Cochlear’s State of Hearing Report coincides with the launch of its Sounds Inevitable campaign, which highlights the misperceptions many people have about hearing loss being an inevitable part of aging, leading to irregular hearing check-ups and delayed treatment.

About State of Hearing Report

The State of Hearing Report 2019 is the result of a five-minute, online survey among a representative sample of n=7,275 adults aged 18 year and older in five countries, including Australia, Germany, Japan, the United Kingdom and the United States. Important global trends emerged about perspectives of how hearing affects individuals and communities after speaking with more than 7,200 people, including more than 1,000 aged 60 years and older with hearing loss. In the U.S., the nationally representative cohort included n=1,061 general population respondents and 208 respondents aged 60 years and older. The survey was fielded between December 12-30, 2018.

About Cochlear Limited (ASX: COH)

Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 3,500 people and invests more than AUD$160 million each year in research and development. Products include cochlear implants, bone conduction implants and acoustic implants, which healthcare professionals use to treat a range of moderate to profound types of hearing loss.

Since 1981, Cochlear has provided more than 550,000 implantable devices, helping people of all ages, in more than 100 countries, to hear.

References
  1. World Health Organization. Deafness & Hearing Loss Factsheet. Available at https://www.who.int/news-room/fact-sheets/detail/deafness-and-hearing-loss [Last accessed Feb 2019]
Please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.
© Cochlear Limited 2019. All rights reserved. Cochlear, Hear now. And always, Nucleus, Baha, the elliptical logo and marks bearing an ® or ™ symbol, are either trademarks or registered trademarks of Cochlear Bone Anchored Solutions AB or Cochlear Limited (unless otherwise noted).
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This material is intended for health professionals. If you are a consumer, please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.

 

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