Cochlear Implants
by Ryan Lopez

Cochlear expands treatment options for individuals with single-sided deafness

March 24, 2022
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By Ryan Lopez, Director, Nucleus Product Management & Marketing

In January 2022, Cochlear received FDA approval to treat patients with single-sided deafness (SSD) with the Cochlear™ Nucleus® System. This approval expands treatment options to include both bone conduction solutions and cochlear implants for these patients.

“This indication allows patients experiencing UHL/SSD to get as close to the normal condition as possible as a cochlear implant restores hearing ability to the ear that has hearing loss. This allows me to provide for my patients so they can get back to the condition that they had been used to before their hearing loss.”

-Eric Lupo, MD Rocky Mountain Ear Center

While this is an extremely important landmark, we want to ensure that professionals have the resources they need to provide the best treatment option for each individual’s unique hearing loss and needs. The first step in the counseling process is to help candidates understand the potential impact of single-sided deafness within their daily lives. While individuals with SSD can function well in relatively easy listening situations, bringing awareness to the disruption in their ability to understand speech in adverse listening situations, their ability to localize sound, and the mental fatigue associated with daily listening efforts, is vital.

Age and duration of hearing loss is a key consideration and starting point for determining the best solution for individuals with single-sided deafness. For children under five years of age, Cochlear offers Softbands and SoundArcs™, non-surgical bone conduction solutions. This is important because early access to improving speech understanding is of highest priority. For children ages five to twelve, Cochlear expands the bone conduction offering with the Baha® Connect and Attract Systems, as well as a portfolio of Nucleus cochlear implant solutions. Finally, for individuals twelve and older, in addition to cochlear implants, the Cochlear Osia® System combines the best high frequency amplification with unique piezoelectric stimulation without a percutaneous abutment.

With regard to cochlear implants, one of the core advantages is the restoration of binaural hearing and improved ability to localize. Candidacy is dependent on the presence of a functioning nerve in the impacted ear and a duration of less than 10 years since the onset of the hearing loss. With acoustic neuroma being one of the leading causes of unilateral hearing loss, the FDA has approved Cochlear to remove the acoustic neuroma contraindication from its labeling.

This ensures that individuals with a functioning nerve, pre- or post-acoustic neuroma removal, can still have a cochlear implant option.

With more options come more decision points. This is why we’re committed to partnering with leading professionals in the industry and developing clinical guidance tools to support you and your patients throughout the journey to better hearing

Please reach out to your local Cochlear Representative to learn more about these solutions and clinical guidance resources.

Read more about the treatment pathway for SSD patients here.

Related Posts

Supporting the benefits of bimodal hearing: ReSound ENZO Q™ and the Smart Hearing Alliance

July 24, 2020

By Natasha McDougald, Product Manager, Bimodal and Hybrid Hearing

Discussions around the importance of acoustic input from both ears in individuals with hearing loss started as a key discussion with Schroers and team in 1985.1  Since then, research has occurred in both the acoustic and electric (cochlear implant) arena, with recent articles discussing electric and acoustic hearing contributing to the bimodal condition. 

Dr. Jennifer Schumacher, audiologist with GN Hearing, recently authored a white paper supporting the benefits of bimodal hearing.  She highlights key benefits of patients in the bimodal condition in the everyday listening environment, and speaks to recent research showing speech understanding improvements with the addition of a hearing aid when compared to using a cochlear implant alone in both quiet and noisy environments.2-4

Real-world benefit was not just limited to speech performance outcomes, but also improvements in rated satisfaction with sound quality and spatial perception.5  These outcomes parallel the results in Cochlear’s Multicenter Study featuring the Slim Modiolar electrode, where patients experienced a 40 percentage point gain in CNC words in quiet and a 24 percentage point improvement in noise.6

Additionally, subjects in the Cochlear study demonstrated an improvement in reported satisfaction with their hearing performance. Pre-operatively, only 9% of subjects reported satisfaction using bilateral hearing aids. Post-operatively, 95% of subjects reported satisfaction in their overall listening ability while wearing a bimodal solution in a device use questionnaire.6

Speech Understanding with Cochlear Implant and Hearing Aid (N=94)

**p = < 0.001

Moreover, while some patients fit bimodally will see benefit, the amount varies from person to person, and others may be appropriately suited for bilateral cochlear implants.  Factors that may affect this outcome include a consistent practice of fitting the other ear acoustically for unilateral cochlear implant recipients, and the amount of hearing benefit gained from the acoustic input.  

Schumacher mentions that participants at the New York University School of Medicine study by  Neuman et al. in 2017 were more likely to discontinue hearing aid use when they had poorer mid-to high-frequency hearing loss in the non-implanted ear and no significant increase in speech understanding with addition of the hearing aid.  She postulates beyond the factors discussed that optimal fitting of the hearing aid may assist in success with bimodal hearing.7

The author introduces the Smart Hearing Alliance, a collaboration between Cochlear and ReSound that aims to develop hearing solutions that meet the advanced innovation needs of both patients and professionals.  Cochlear and ReSound have released an updated fitting flow with simple steps designed to maximize audibility, incorporating loudness balancing driven by conversational speech, and supports selection by the hearing healthcare provider of various fitting rationales including the ReSound proprietary Audiogram+.  Instruction is also provided to enable direct wireless streaming and assist in wireless accessory setup.

The Smart Hearing Alliance’s implementation of connectivity allows patients to take advantage of direct streaming to both ears from compatible smartphones. Further, use of wireless accessories has been confirmed by independent studies increase a bimodal patient’s speech understanding via mobile phone and to supply signal-to-noise ratio improvements, which could aid speech understanding in noisy environments. 8-9

The new ReSound ENZO Q™ behind-the-ear hearing aid for severe-to-profound hearing losses may be uniquely suited to the needs of a bimodal patients.  It offers an upgraded chip allowing direct connectivity to compatible Apple® or Android™ smartphones* and has an IP rating standard of 68 and completely nanocoated to assist in resistance to moisture and to increase durability.  To provide high quality amplification of the wide range of everyday sounds, the ReSound ENZO Q 98 model features an increased input dynamic range extending to 113 dB SPL as well as 145 SPL peak output.  Bimodal patients who want to travel less, or are served by a separate cochlear implant audiologist and HCP, can use the ReSound Smart 3DTM app on their compatible smartphones to take advantage of ReSound Assist Live for live synchronous support or remote hearing aid fine-tuning requests via the asynchronous ReSound Assist feature. These types of remote features may be especially useful for patients and their clinicians when navigating this new patient care paradigm.

To stay up to date on the latest industry topics, subscribe to Cochlear ProNews and read the article now.

About the author: Natasha has worked at Cochlear Americas for almost 9 years partnering with clinicians and surgeons at the University of Miami, UCSF, Stanford, UC Davis and UCSF Benioff Children’s Hospital of Oakland to bring cochlear implants to pediatric and adult patients.  Extremely passionate, Natasha is professionally and personally invested in the implantable hearing industry and strives to forward the cause of those affected by hearing loss. 

References:

  1. Schroers, K.K & Olsen, W.O. (1985).  Comparison of Monaural and Binaural Hearing Aid Use on a Trial Period Basis. Ear and Hearing, 6(4), 198-202
  2. Potts LG, Skinner MW, Litovsky RA, Strube MJ, Kuk F. Recognition and localization of speech by adult cochlear implant recipients wearing a digital hearing aid in the nonimplanted ear (bimodal hearing). Journal of the American Academy of Audiology. 2009;20(6):353-73.
  3. Ching TY, Incerti P, Hill M. Binaural benefits for adults who use hearing aids and cochlear implants in opposite ears. Ear and Hearing. 2004;25(1):9-21.
  4. Ching TY, Van Wanrooy E, Dillon H. Binaural-bimodal fitting or bilateral implantation for managing severe to profound deafness: A review. Trends in Amplification. 2007;11(3):161-92.
  5. Schafer EC, Amlani AM, Paiva D, Nozari L, Verret S. A meta-analysis to compare speech recognition in noise with bilateral cochlear implants and bimodal stimulation. International Journal of Audiology. 2011;50(12):871-80.
  6. Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implants in Adults Investigator Meeting. 2019 Apr.
  7. Neuman AC, Waltzman SB, Shapiro WH, Neukam JD, Zeman AM, Svirsky MA. Self-reported usage, functional benefit, and audiologic characteristics of cochlear implant patients who use a contralateral hearing aid. Trends in Hearing. 2017;21:1-14.
  8. Wolfe J, Morais M, Schafer E. Speech recognition of bimodal cochlear implant recipients using a wireless audio streaming accessory for the telephone. Otology & Neurotology. 2016;37(2):20-5.
  9. Vroegop JL, Dingemanse JG, Homans NC, Goedegebure A. Evaluation of a wireless remote microphone in bimodal cochlear implant recipients. International Journal of Audiology. 2017;56(9):643-9.

The Cochlear Nucleus 7 Sound Processor is compatible with iPhone, iPad and iPod touch. Apple, the Apple logo, FaceTime, Made for iPad logo, Made for iPhone logo, Made for iPod logo, iPhone, iPad Pro, iPad Air, iPad mini, iPad and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.

The Cochlear Nucleus Smart App is available on App Store and Google Play. For complete smartphone compatibility information, please visit www.cochlear.com/compatibility.

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Dr. Jace Wolfe

New TECH Talk: Age of implantation and critical development window

May 11, 2020

Dr. Jace Wolfe, clinical audiologist and Director of Audiology and Research at the Hearts for Hearing Foundation in Oklahoma City, uses his 22 years of cochlear implant experience to examine results from the Longitudinal Outcomes of Children with Hearing Impairment (LOCHI) Study based out of Australia to understand the long-term impact of age at implantation. The March 2020 FDA approval to expand pediatric indications to nine months further reinforces the urgency to give pediatric patients early access to sound, especially as they reach hearing and language milestones.

Moreover, the LOCHI study observed children from the age of hearing loss identification until early adulthood to explore speech, language, literacy, auditory, educational, vocational, social and pragmatic outcomes. Wolfe further recaps the factors that may influence hearing outcomes such as age of implantation.

Key finding of the LOCHI Study:

  • For every 6-month delay in implantation there’s a ½ standard deviation (about seven points from the mean score for a standardized measure of language ability) reduction in their language outcomes.1,2

This suggests the presence of a critical window for language development and auditory stimulation. Through partnership, together we can reach further to give pediatric patients early access to sound.

“Every moment within that critical period counts,” Wolfe concludes.

To learn more about early implantation visit our TECH Talks page or website.

References:

  1. Ching, T.Y., Dillon, H., Leigh, G., & Cupples, L. (2018). Learning from the longitudinal outcomes of children with hearing impairment (LOCHI) study: summary of 5-year findings and implications. International Journal of Audiology, 57(2), S105-S111.
  2. Ching, T.Y., Dillon, H., Button, L., Seeto, M., Buynder, P.V., Marnane, V., Cupples, L., & Leigh, G. (2017). Age at Intervention for Permanent Hearing Loss and 5-Year Language Outcomes. Pediatrics, 140 3.

In the US, the cochlear implant system is intended for use in children 9 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children two years of age or older may demonstrate severe to profound hearing loss bilaterally. In the Canada, the cochlear implant system is intended for use in children 12 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children two years of age or older may demonstrate severe to profound hearing loss bilaterally.

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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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