Quick report by AQuAS on indication criteria for cochlear implants in children in Spain

In April 2019, the Catalan Agency for Quality and Healthcare Evaluation, AQuAS, published a quick report with indication criteria for cochlear implants (CI) in children.

This quick report aimed at updating the indication criteria for CI in children that were described in the previous report from November 2018 published by AQuAS and titled “Effectiveness and cost-effectiveness of bilateral cochlear implants in children and adults.” MTRC reported on the original assessment, which can be seen here.

The search for evidence aimed at identifying guidelines, positioning reports from scientific societies and systematic reviews on the criteria for the indication of CI in children in the following databases: MEDLINE/PubMed, The Cochrane Library, UpToDate, RedETS and Google (advanced search) until December 2018.

The criteria for the indication of CI in children described in the AQuAS 2018 report (Annex 1, pages 55-57) have been modified. The changes are based on three documents selected for being very recent (2018) and having been developed by relevant entities at the methodological level and knowledge and experience in the subject of study.

Criteria for indication of CI to children (grade recommendation from [A] to [D], [A] being the highest quality recommendation; good clinical practice [√]).

Criterion 1: Severe bilateral sensorineural hearing loss (hearing loss 71-90 dB) to profound (hearing loss> 90 dB) or total (hearing loss> 119 dB) in children 5 years old up to 17 years old [grade C]

• The ideal age to recommend the IC is between 12 months and 4 years of age when a great benefit is reached, and its performance decreases when implanted in children between 4 and 7 years old. In those older than 7 years, the performance of the IC will be lower, and an individual assessment is needed and always a period of hearing aid tests for 3-6 months [√]. Before 12 months of age, the benefit of the CI is uncertain in the absence of prospective studies or with long term follow-ups. In some cases, the lower age limit is marked by safety diagnosis to determine the degree of hearing loss and that the trained personnel and adequate means requirements are met so that the anesthetic and surgical risk of a child younger than one year is comparable to that of an older child
• Implantation at an early age may be justified in the case of post meningitis hearing loss whose course is often complicated by the formation of scars and ossification within the cochlea
• The recommendations of the current vaccination calendar should be followed

Criterion 2: Pre-locutive, peri-locutive and post-lingual hearing loss [C]

Criterion 3: No benefit or minimal benefit with hearing aid according to (silent) language recognition test score after a 3-6-month trial period [D]

• It is considered that the benefit is insufficient if the tonal thresholds at conversational frequencies are higher than 50 dB, or the recognition of disyllables is less than 40% (in lists of standardized and balanced words in open context and at 65 dB in silence) [√]
• Before 5 years of age, it is not possible to perform oral audiometry tests in the absence of language development. Therefore, tonal threshold determinations must be made, either with behavioral or objective audiometry by auditory evoked potentials [√]
• In children, during the testing period, speech, language and comprehension skills should be assessed, taking into account the age, developmental status and cognitive ability of each child [D]
• In very young children, the testing time has to be extended to ensure that the maximum possible benefit has been obtained [D]
• The tests must take into account the person's disabilities, whether physical or cognitive, linguistic or other and adapt them when necessary. If it is not possible to administer a test due to a lack of skills to do it properly, other tests will be considered [D]

Criterion 4: A prior psychological and neurological evaluation is required to confirm the benefit that the cochlear implant will bring [D]

• A psychological evaluation prior to the cochlear implant is recommended as a point of reference to evaluate the impact of the cochlear implant in the adaptation of the child to his new situation [D]

Criterion 5: Preoperative evaluation. Perform diagnostic imaging (computed tomography [CT], magnetic resonance imaging [MRI], or both) that demonstrate the existence of a cochlea sufficiently developed to house the electrode and confirm the presence of the cochlear nerve [√]

When these five criteria are met, it is recommended to perform a bilateral IC (ICB) rather than unilateral (ICU) and, simultaneously or minimizing the time between implants (if it is possible, in a less than one-year interval).

• Given that it is the parents of children with hearing loss who are responsible for deciding on the insertion or not of the IC, it is very important to guarantee the informed medical consent [√]
• The decision to make an IC must be shared with the parents of the child and therefore adequate information should be provided on the surgical procedure, auditory rehabilitation, and subsequent care. It is essential to work together to adapt the expectations of the parents to later reality

Considerations:

• Among the benefits of the bilateral CI is that they allow the child to hear better in conditions of environmental noise (for example, restaurants), locate the sound and listen to the sound that comes from both sides without having to turn the head. Arguments against bilateral implantation are, having a greater anesthetic and surgical risk, risk of residual hearing loss and preserve an ear for future technologies
• In the bilateral CI, the insertion can be done in the same surgical act (simultaneous bilateral CI) or in two, consecutive surgeries (deferred or sequential bilateral CI). Some studies show the benefit of the ICB with any duration between surgeries. However, greater development of expressive language in patients is observed with a minimum duration between implants, with the highest response observed in patients with simultaneous implantation
• When the cause of hearing loss is infectious or is associated with other disabilities, the option of the simultaneous bilateral CI would have to be the intervention to recommend. These conditions are the following [√]: hypoacusia postmeningitis or postcytomegalovirus or postinfectious, hypoacusia associated with blindness, the presence of other multisensory deficits and USHER syndrome (associated with progressive loss of view)
• When the child already has a unilateral CI, and other pathologies are present, or the evolution is not the expected, the option of the bilateral CI is the recommended surgical alternative. The situations in which a second implant would have to be added are the following [√]:
  • malformations of the inner ear with little unilateral functional result
  • attention deficit hyperactivity disorder (ADHD) or other behavioral disorders associated with hearing loss
  • when there is a new pathology that can interfere with the results of the first implant and
  • Pendred syndrome or other hereditary diseases that are associated with progressive bilateral loss

See the full report in Spanish here.

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