Cochlear Implants for Children Aged Two Years and

TITLE: Cochlear Implants for Children Aged Two Years and Younger: Comparative
Clinical Effectiveness and Guidelines
DATE: 10 December 2015
RESEARCH QUESTIONS
1.
What is the clinical effectiveness of unilateral or bilateral cochlear implantation in pediatric
patients, aged two years and younger, with hearing impairment, compared with unilateral
or bilateral cochlear implantation in pediatric patients older than two years?
2.
What are the evidence-based guidelines regarding cochlear implantation in pediatric
patients aged two years and younger?
KEY FINDINGS
One systematic review and eight non-randomized studies were identified regarding the clinical
effectiveness of cochlear implantation in pediatric patients, aged two years and younger, with
hearing impairment, compared with cochlear implantation in pediatric patients older than two
years. No evidence-based guidelines were identified.
METHODS
A limited literature search, with main concepts appearing in the title, the keyword field or as a
major subject heading, was conducted on key resources including Ovid Medline, PubMed, The
Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases,
ECRI Institute, Canadian and major international health technology agencies, as well as a
focused Internet search. Methodological filters were applied to limit retrieval to health
technology assessments, systematic reviews, meta-analyses, randomized controlled trials, nonrandomized studies and guidelines. Where possible, retrieval was limited to the human
population. The search was also limited to English language documents published between
January 1, 2010 and November 27, 2015. Internet links were provided where available.
Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in
Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic review s. The intent is to
provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts w ithin the time
allow ed. Rapid responses should be considered along w ith other types of information and health care considerations. The
information included in this response is not intended to replace professional medical advice, nor should it be construed as a
recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality
evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for
w hich little information can be found, but w hich may in future prove to be effective. While CADTH has taken care in the preparation
of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that ef fect.
CADTH is not liable for any loss or damages resulting from use of the information in the report.
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ow ner.
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The summary of findings was prepared from the abstracts of the relevant information. Please
note that data contained in abstracts may not always be an accurate reflection of the data
contained within the full article.
SELECTION CRITERIA
One reviewer screened citations and selected studies based on the inclusion criteria presented
in Table 1.
Table 1: Selection Criteria
Population
Intervention
Comparator
Outcomes
Study Designs
Pediatric patients, aged two years and younger, with hearing impairment
Unilateral or bilateral cochlear implantation
Unilateral or bilateral cochlear implantation in pediatric patients older than
two years, with hearing impairment
Q1: Improved speech or competent use of speech
Q2: Evidence-based guidelines
Health technology assessments, systematic reviews, meta-analyses,
randomized controlled trials, non-randomized studies, guidelines
RESULTS
Rapid Response reports are organized so that the higher quality evidence is presented first.
Therefore, health technology assessment reports, systematic reviews, and meta-analyses are
presented first. These are followed by randomized controlled trials, non-randomized studies,
and evidence-based guidelines.
One systematic review and eight non-randomized studies were identified regarding the clinical
effectiveness of cochlear implantation in pediatric patients, aged two years and younger, with
hearing impairment, compared with cochlear implantation in pediatric patients older than two
years. No health technology assessments, randomized controlled trials, or evidence-based
guidelines were identified.
Additional references of potential interest are provided in the appendix.
OVERALL SUMMARY OF FINDINGS
A systematic review of the literature, published in 2011,1 reported that children who received
cochlear implants within the first year of life and many of those receiving implants before 18
months of age, attained a learning advantage over those who were implanted later in life. It also
reported that sequential bilateral implantation, with a short interval between interventions, was
advantageous.
Eight non-randomized studies were identified, and are summarized in Table 2. All studies
except two2,8 indicated that children receiving cochlear implants by two years of age
experienced better outcomes over time than children receiving cochlear implants at later ages.
Cochlear Implants for Children aged Two Years and Younger
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First author, Year
2
Dunn, 2014
Table 2: Summary of Non-Randomized Studies
Intervention and Comparator
Outcomes
Implantation at < 2 years versus
between 2 and 3.9 years
3
Liu, 2014
Implantation at < 2 years versus >
2 years in children with auditory
neuropathy spectrum disorder
4
Ramos-Macias, 2014
5
Geal-Dor, 2013
Guerra-Jimenez,
6
2013
7
Tobey, 2013
Sequential bilateral implantation
at < 2 years (with interplant period
of ≤ 4 years) versus > 2 years
Implantation at < 2.5 years versus
between 2.5 and 5 years
8
Szagun, 2012
9
Colletti, 2011
Sequential bilateral implantation
at < 2 years (with interplant period
of ≤ 4 years) versus implantation
between 3 to 5 years;
Implantation at < 2 years versus
between 2 and 6 years
Implantation at < 2 years versus
between 2 and 3.5 years
Implantation at 2 to 11 months
versus 12 to 23 months versus 24
to 35 months
Impact on outcomes after 7 to 13 years of
implantation
The effect on skills such as language and
reading diminishes over time.
Impact on outcomes after 12-84 months of
implantation
Children receiving implants at < 2 years of
age acquired better auditory and speech
skills than those implanted at > 2 years of
age.
Impact on outcomes at 12 years of age
Audiology, language development, and
linguistic competence were better for the
younger group.
Time of outcome measurements not
reported in abstract
Younger children achieved auditory
milestones later than children implanted in
the older group.
Impact on outcomes at 12 years of age
Better verbal discrimination for the children
implanted at < 2 years, with interplant
period of ≤ 4 years
Impact on outcomes after 4, 5, and 6 years
of implantation
Higher levels of performance with earlier
implantation group;
after 6 years of implantation language
outcomes associated with the 2 groups
were variable
Impact on outcomes after 12, 18, 24, and
30 months of implantation
No overall effect of age at implantation;
children with early implantation showed
marked progress early, while those with
later implantation progressed later on.
Impact on outcomes after 12 to 36 months
of implantation
Youngest group had better auditory
performance than the older groups.
Impact on outcomes after 5 and 10 years of
implantation
Youngest group had significantly better
grammar skills and cognitive performances
than the older groups.
Cochlear Implants for Children aged Two Years and Younger
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REFERENCES SUMMARIZED
Health Technology Assessments
No literature identified.
Systematic Reviews and Meta-analyses
1.
Forli F, Arslan E, Bellelli S, Burdo S, Mancini P, Martini A, et al. Systematic review of the
literature on the clinical effectiveness of the cochlear implant procedure in paediatric
patients. Acta Otorhinolaryngol Ital [Internet]. 2011 Oct [cited 2015 Dec 9];31(5):281-98.
Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3262414
PubMed: PM22287820
Randomized Controlled Trials
No literature identified.
Non-Randomized Studies
2.
Dunn CC, Walker EA, Oleson J, Kenworthy M, Van Voorst T, Tomblin JB, et al.
Longitudinal speech perception and language performance in pediatric cochlear implant
users: the effect of age at implantation. Ear Hear [Internet]. 2014 Mar [cited 2015 Dec
9];35(2):148-60. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3944377
PubMed: PM24231628
3.
Liu Y, Dong R, Li Y, Xu T, Li Y, Chen X, et al. Effect of age at cochlear implantation on
auditory and speech development of children with auditory neuropathy spectrum disorder.
Auris Nasus Larynx. 2014 Dec;41(6):502-6.
PubMed: PM25194855
4.
Ramos-Macias A, Borkoski-Barreiro S, Falcon-Gonzalez JC, Plasencia DP. Results in
cochlear implanted children before 5 years of age. a long term follow up. Int J Pediatr
Otorhinolaryngol. 2014 Dec;78(12):2183-9.
PubMed: PM25455526
5.
Geal-Dor M, Tranovsky Y, Boudilovsky E, Adelman C, Adler M, Levi H. Acquisition of early
auditory milestones with a cochlear implant. Int J Pediatr Otorhinolaryngol. 2013
Nov;77(11):1852-5.
PubMed: PM24063769
6.
Guerra-Jimenez G, Viera AJ, Mateos M, Gonzalez AR, Falcon Gonzalez JC, Borkoski BS,
et al. Communication benefits of bilateral cochlear implantation. Retrospective study in 12year-old children. Acta Otorrinolaringol Esp. 2013 Nov;64(6):409-15.
PubMed: PM24148805
7.
Tobey EA, Thal D, Niparko JK, Eisenberg LS, Quittner AL, Wang NY, et al. Influence of
implantation age on school-age language performance in pediatric cochlear implant users.
Int J Audiol [Internet]. 2013 Apr [cited 2015 Dec 9];52(4):219-29. Available from:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3742378
PubMed: PM23448124
Cochlear Implants for Children aged Two Years and Younger
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8.
Szagun G, Stumper B. Age or experience? The influence of age at implantation and social
and linguistic environment on language development in children with cochlear implants. J
Speech Lang Hear Res. 2012 Dec;55(6):1640-54.
PubMed: PM22490622
9.
Colletti L, Mandala M, Zoccante L, Shannon RV, Colletti V. Infants versus older children
fitted with cochlear implants: performance over 10 years. Int J Pediatr Otorhinolaryngol.
2011 Apr;75(4):504-9.
PubMed: PM21277638
Guidelines and Recommendations
No literature identified.
PREPARED BY:
Canadian Agency for Drugs and Technologies in Health
Tel: 1-866-898-8439
www.cadth.ca
Cochlear Implants for Children aged Two Years and Younger
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APPENDIX – FURTHER INFORMATION:
Systematic Reviews – Uncertain Comparator
10.
Wolff R, Hommerich J, Riemsma R, Antes G, Lange S, Kleijnen J. Hearing screening in
newborns: systematic review of accuracy, effectiveness, and effects of interventions after
screening. Arch Dis Child. 2010; 95(2): 130-135
PubMed: PM19329444
Non-Randomized Studies – Alternate Comparator
11.
Cuda D, Murri A, Guerzoni L, Fabrizi E, Mariani V. Pre-school children have better spoken
language when early implanted. Int J Pediatr Otorhinolaryngol. 2014 Aug;78(8):1327-31.
PubMed: PM24916102
12.
Holman MA, Carlson ML, Driscoll CL, Grim KJ, Petersson RS, Sladen DP, et al. Cochlear
implantation in children 12 months of age and younger. Otol Neurotol. 2013
Feb;34(2):251-8.
PubMed: PM23444471
13.
Leigh J, Dettman S, Dowell R, Briggs R. Communication development in children who
receive a cochlear implant by 12 months of age. Otol Neurotol. 2013 Apr;34(3):443-50.
PubMed: PM23442570
14.
Zhou H, Chen Z, Shi H, Wu Y, Yin S. Categories of auditory performance and speech
intelligibility ratings of early-implanted children without speech training. PLoS ONE
[Internet]. 2013 [cited 2015 Dec 9];8(1):e53852. Available from:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3549925
PubMed: PM23349752
15.
Colletti L, Mandala M, Colletti V. Cochlear implants in children younger than 6 months.
Otolaryngol Head Neck Surg. 2012 Jul;147(1):139-46.
PubMed: PM22454156
16.
May-Mederake B. Determining early speech development in children with cochlear
implants using the ELFRA-2 parental questionnaire. Int J Pediatr Otorhinolaryngol. 2012
Jun;76(6):797-801.
PubMed: PM22465105
17.
Schramm B, Bohnert A, Keilmann A. Auditory, speech and language development in
young children with cochlear implants compared with children with normal hearing. Int J
Pediatr Otorhinolaryngol. 2010 Jul;74(7):812-9.
PubMed: PM20452685
Non-Randomized Studies – Safety
18.
O'Connell BP, Holcomb MA, Morrison D, Meyer TA, White DR. Safety of cochlear
implantation before 12 months of age: Medical University of South Carolina and Pediatric
American College of Surgeons-National Surgical Quality improvement program outcomes.
Laryngoscope. 2015 Aug 26.
Cochlear Implants for Children aged Two Years and Younger
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PubMed: PM26308472
19.
Cohen MS, Ha AY, Kitsko DJ, Chi DH. Surgical outcomes with subperiosteal pocket
technique for cochlear implantation in very young children. Int J Pediatr Otorhinolaryngol.
2014 Sep;78(9):1545-7.
PubMed: PM25064628
20.
Anagiotos A, Beutner D. The impact of blood loss during cochlear implantation in very
young children. Eur Arch Otorhinolaryngol. 2013 Sep;270(9):2439-44.
PubMed: PM23179935
Non-Randomized Studies – Additional Considerations
21.
Bovo R, Trevisi P, Ghiselli S, Benatti A, Martini A. Is very early hearing assessment
always reliable in selecting patients for cochlear implants? A case series study. Int J
Pediatr Otorhinolaryngol. 2015 May;79(5):725-31.
PubMed: PM25799382
22.
De Kegel A, Maes L, Van Waelvelde H, Dhooge I. Examining the impact of cochlear
implantation on the early gross motor development of children with a hearing loss. Ear
Hear. 2015 May;36(3):e113-e121.
PubMed: PM25551409
23.
Boons T, Brokx J, Frijns J, Philips B, Vermeulen A, Wouters J, et al. Newborn hearing
screening and cochlear implantation: impact on spoken language development. B-ENT.
2013;Suppl 21:91-8.
PubMed: PM24383227
24.
Semenov YR, Yeh ST, Seshamani M, Wang NY, Tobey EA, Eisenberg LS, et al. Agedependent cost-utility of pediatric cochlear implantation. Ear Hear [Internet]. 2013 Jul
[cited 2015 Dec 9];34(4):402-12. Available from:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3744006
PubMed: PM23558665
Guidelines and Recommendations – Methodology not Specified
25.
Patel H, Feldman M. Universal newborn hearing screening. Paediatr Child Health
[Internet]. 2011 May; reaffirmed 2014 Feb [cited 2015 Dec 9];16(5):301-10. Available from:
http://www.cps.ca/en/documents/position/universal-hearing-screening-newborns
PubMed: PM22547950
26.
Ear, Nose and Throat Advisory Group. Clinical guidelines for paediatric cochlear
implantation [Internet]. Perth: Department of Health, Western Australia; 2011 May. [cited
2015 Dec 9]. Available from:
http://www.healthnetworks.health.wa.gov.au/docs/2011_CI_Guideline.pdf
See: Section 1.5 Timing of Cochlear Implants
27.
Healthy hearing program: medical guidelines for children born with a permanent hearing
loss [Internet]. Version 7. Brisbane (AU): Queensland Government; 2010 Mar; updated
Cochlear Implants for Children aged Two Years and Younger
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2012 May 24. [cited 2015 Dec 9]. Available from:
https://www.health.qld.gov.au/healthyhearing/docs/medicalguide12.pdf
See: Healthy Hearing Benchmarks
Additional References
28.
Houston DM, Bergeson TR. Hearing versus listening: attention to speech and its role in
language acquisition in deaf infants with cochlear implants. Lingua [Internet]. 2014 Jan 1
[cited 2015 Dec 9];139:10-25. Available from:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3979557
PubMed: PM24729634
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