Audiology

Vol. 45: Issue 1 - February 2025

Cochlear implant procedure. Italian Clinical Practice Guidelines of the Italian Society of Otorhinolaryngology (SIOeChCF) and Italian Society of Audiology and Phoniatrics (SIAF). Part 1: cochlear implants in adults

Authors

Key words: cochlear implant, hearing loss, adult patients, guidelines, clinical practice recommendation
Publication Date: 2025-03-14

Abstract

Cochlear implant is a well-established treatment for adults with sensorineural hearing loss without benefit from hearing aids.
Cover figure: Cochlear implant is a well-established treatment for adults with sensorineural hearing loss without benefit from hearing aids.

Objective. Cochlear implant (CI) is a well-established treatment for adults with sensorineural hearing loss and without benefit from hearing aids. The Italian guidelines date back 15 years; given the expansion of indications for CI, including single side deafness and asymmetrical hearing loss, it became necessary to establish updated guidelines.
Methods. Thirteen experts and 2 patient representatives selected the key questions and drew up recommendations. The document was developed following GRADE methodology. The methodological team of the Mario Negri Pharmacological Research Institute performed systematic reviews for each question and supported the overall process.
Results. Five key questions were identified and recommendations formulated, with subgroups and considerations on implementation.
Conclusions. Though the systematic research of scientific literature found a scarcity of randomised trials and an overall poor conduct and reporting quality of primary studies and systematic reviews, strong or conditional recommendations in favour of CI have been formulated for different subgroups of patients. Further studies should enrol a larger number of participants and use consistent instruments to evaluate hearing outcomes, in order to increase the comparability of results and data pooling with meta-analysis.

Introduction

This report summarises the recommendations of Clinical Practice Guidelines regarding cochlear implant (CI) procedure in adults 1, drawn up according to the GRADE methodology 2 and promoted by the Italian Society of Otorhinolaryngology (SIOeChCF) and Italian Society of Audiology and Phoniatrics (SIAF). Current knowledge on CI procedures is translated into relevant practical recommendations following the rules and the methodology indicated by the Centro Nazionale per l’Eccellenza delle Cure (CNEC) and the Istituto Superiore di Sanità (ISS).

CI is a well-established, safe and effective treatment for adults with sensorineural hearing loss who do not benefit from traditional hearing aids. In the adult patient, deafness, if untreated, causes difficulties in communication and social interactions, hindering the development of potential in all spheres, including work and social relationships 3,4.

The US Food and Drug Administration (FDA) 5 approved the use of CIs in adults in 1984. Initially, CI was only dedicated to patients with profound bilateral hearing loss. Subsequently, the indications for this procedure were broadened, mainly on the basis of extremely positive clinical evidence and technological advances, which allowed for faster, safer and less invasive surgery as well as better outcomes. Consequently, the procedure was also considered for subjects with greater residual hearing, asymmetrical hearing loss, or even unilateral deafness (so-called single sided deafness, SSD). In addition, simultaneous or sequential bilateral procedures are currently available for certain types of patients. However, some of the more recent areas of application of the procedure are still debated, since the evidence on clinical benefits and cost effectiveness is limited.

Although several guidelines have been published that define the indications for the procedure in the adult patient, there is no uniformity on the criteria that are considered by various groups to define its appropriateness. Moreover, the currently available guidelines are mostly national and their structure is not defined and universally shared.

In Italy, in 2009, guidelines for the CI procedure were published by a working group coordinated by the SIOeChCF 6. These guidelines date to 15 years ago and, given the enormous expansion of indications for CI, in some aspects should considered outdated, since they do not consider some areas in which CI is currently indicated (e.g., SSD, asymmetrical hearing loss, etc.). Furthermore, in 2011 a Health Technology Assessment (HTA) project, promoted by the Italian Ministry of Health, was concluded by a working group of experts coordinated by Berrettini 7 to outline the appropriateness criteria of the CI procedure in adults and children. This document does not consider certain aspects, such as CI in asymmetrical hearing loss and SSD, and does not reflect criteria for a proper guideline.

For these reasons, it became necessary to establish new and updated guidelines on the criteria for selection and appropriateness of the CI procedure in adult patients. In particular, attention was paid to unilateral or bilateral implantation and to CI in asymmetrical hearing loss and SSD.

Materials and methods

The panel was composed by 3 otolaryngologists, 2 audiologists/phoniatricians, one audiometrist, one hearing aid specialist, one speech pathologist, one pediatric neuropsychiatrist, one geneticist, one geriatrician, one neuroradiologist, one psychologist and 2 patient representatives. The experts, indicated by the above-mentioned scientific societies, and the patient representatives identified, by collegial discussion, the key questions that healthcare providers are frequently faced with, discussed the evidence provided by the methodological team and drew up guidelines.

This document was developed according to the rules of the Centro Nazionale per l’Eccelenza delle Cure (CNEC) of the Italian Ministry of Health with the support of the methodological team of the Laboratory of Methodology of Systematic Reviews and Guidelines production of the Mario Negri Pharmacological Research Institute. The key questions were developed according to the Population, Intervention, Comparison, Outcomes (PICO) acronym. For each PICO question, the literature on MEDLINE/PubMed, Embase and Cochrane Library databases was systematically searched with both thesaurus terms and free text up to June 2023 and included systematic reviews, randomised and non-randomised controlled trials and non-controlled studies. A further hand search was performed on the bibliography of retrieved articles.

Recommendations were formulated applying the GRADE approach2 according to the CNEC manual 8. All aspects concerning questions, assessment of evidence and conclusions were discussed among panel members and voted upon. Before voting, members declared their potential conflict of interests (COI) relevant to the PICO question, and only those without COI voted. The online GRADEpro GDT tool was used to develop questions, assess evidence, and make decisions 9. The certainty of evidence was assessed applying the tool for Risk of Bias (RoB) in randomised trials as suggested by Cochrane 10. The methodological quality of systematic reviews was evaluated by the AMSTAR 2 checklist 11.

Results

Table I summarises the PICO questions about Treatment, Recommendations, Certainty of evidence, and Strength of recommendation of CI procedures in adult recipients.

Key Question 1. In an adult patient (age ≥ 18 years) with bilateral severe-profound hearing loss (PTA 0.5-1-2-4 kHz ≥ 75 dB) and poor performance/unsatisfactory outcomes with hearing aids, is cochlear implantation indicated?

Hearing loss in adults is a frequent disorder representing the third leading cause of disability worldwide 12. The number of adults with hearing loss globally is also expected to increase over the next 30 years 12.

Untreated hearing impairment can compromise access to oral communication resulting in emotional effects, isolation, social problems, reduced employment opportunities, and worsened quality of life 13-15.

There is well-established evidence in the literature that cochlear implantation is the gold standard to restore hearing ability for adults with severe hearing loss 16. However, there are few and not universally agreed upon guidelines regarding candidacy criteria for CI 4,17. Sixteen systematic reviews were analysed 3,18-32 published between 2010 and 2022 that included a total of 228 primary studies, mostly case series or case reports with evaluations performed before and after cochlear implantation. The majority of studies included patients with postverbal hearing loss receiving unilateral implantation.

Most of the reviews were of low methodological quality and did not conduct meta-analyses because of the heterogeneity of the instruments used to assess outcomes, length of follow-up, and poor quality of reporting of primary studies.

All the reviews that evaluated quality of life reported an improvement after CI, assessed both by generic (SSQ questionnaire, APHAB) and symptom-specific instruments (NCIQ, HHI-E and HHIA questionnaires) 18,20,23,25. In addition, all studies that assessed subjective benefits reported an improvement in the SSQ questionnaire score. All systematic reviews that evaluated audiometric outcomes reported improved hearing threshold and speech perception with cochlear implantation 3,20-23,25,31,32.

The undesirable effects observed were facial nerve stimulation and incomplete array insertion reported in 10-12% of participants, all of whom with otosclerosis 19,28, tinnitus, reported in 5.6% and 47% of cases 19,23,30, dizziness, reported in 2.2% and 30.9% of patients with percentages increasing with age 23,26,27, skin complications reported in about 6% of participants 22,24, and surgery failures reported in 5.5% 29.

COST-EFFECTIVENESS

Economic evaluations conducted in the United Kingdom indicate that unilateral cochlear implantation in adults with severe/profound deafness is likely to be cost-effective compared with non-implantation or prosthetic hearing aids (willingness to pay range £30,000 to €50,000 per QALY gained) 20,33. An economic analysis conducted in Sweden 34 indicated that unilateral CI is a cost-effective option to improve hearing in Swedish adults with severe to profound deafness and who had previously gained some benefit from hearing aids (willingness to pay SEK 250,000 per QALY gained).

Recommendation: in adult patients (age ≥ 18 years) with bilateral severe-profound hearing loss (PTA 0.5-1-2-4 kHz ≥ 75 dB) and poor performance/unsatisfactory outcomes with hearing aids, the panel recommends cochlear implantation (unilateral, bilateral simultaneous, bilateral sequential) over hearing aids/no intervention.

Certainty of evidence: moderate for quality of life, judged by the panel to be of critical importance, very low for perception of language/communication, low for undesirable outcomes.

Strength of recommendation: strong in favour of CI.

Considerations in subgroups: for patients with auditory neuropathy, elderly patients, patients with preverbal deafness or with major middle and inner ear malformations and/or associated otologic pathologies, cochlear implantation is still recommended, although the benefits achieved may be less and the indications deserve to be evaluated on a case-by-case basis.

Considerations for implementation: in the pre-implant audiological evaluation of patients who are candidates for the intervention, the following exams should be performed: tonal audiometric examination, speech audiometric examination, speech perception test in silence and noise both with hearing aids and without devices. It is recommended that patient management during selection for cochlear implantation be multidisciplinary (audiologist, otolaryngologist, otosurgeon, audiometrist, speech pathologist, radiologist, hearing aid specialist). It is also recommended that postoperative management and follow-up of the patient should be handled by an appropriate team at the CI centre.

Key Question 2. In an adult patient (age ≥ 18 years) with bilateral severe-profound hearing loss (PTA 0.5-1-2-4 kHz ≥ 75 dB) and poor performance/unsatisfactory outcomes with hearing aids, is simultaneous bilateral cochlear implantation indicated?

In an adult subject with bilateral profound deafness who does not sufficiently benefit from the use of prosthetic hearing aids, it is still debated whether the use of a CI in only one ear is sufficient to ensure “socially” useful hearing, or whether bilateral cochlear implantation, especially when performed simultaneously in both ears, makes a significant contribution to the ability to understand verbal communication and, therefore, to the quality of life. There is also evidence that restoration of binaural hearing provides the ability to identify a sound source and improves speech comprehension in environments with background noise. One randomised trial 35 and 10 observational studies 36-45 were reviewed, involving a total of 273 patients.

Seven studies evaluated speech perception in silence: in the randomised study 35 there was no significant difference between unilateral and bilateral simultaneous implants; in contrast, in 6 observational studies the evidence was in favour of bilateral implants 36,37,39,41-44. The randomised study 35 and 7 observational studies 36,37,39-41,44 evaluated speech perception in noise: the randomised study found no significant differences, while the evidence was in favour of simultaneous bilateral implantation in 5 of 7 observational studies.

Sound localisation ability was assessed in the randomised trial35 and in 6 observational studies 38,40-43,45; in all studies sound localisation ability was better with simultaneous bilateral CI.

Only one study assessed quality of life benefits 35 with the speech, spatial and qualities (SSQ) questionnaire; the study reported postoperative improvement in 2 of the 3 subscales of the SSQ.

Only the randomised trial 35 reported adverse events; simultaneous performance of bilateral rather than unilateral implants does not appear to result in increased frequency of tinnitus; no other major complications were reported. The expected frequency of intervention-related adverse events does not differ from that observed with unilateral implantation.

COST EFFECTIVENESS

Three studies comparing simultaneous versus sequential bilateral implantation extracted from a systematic review 46 conducted in the UK and the Netherlands reported that simultaneous bilateral implantation is not cost effective.

Recommendation: for adult patients (age ≥ 18 years) with bilateral severe-profound hearing loss (PTA 0.5-1-2-4 kHz ≥ 75 dB) and poor performance/unsatisfactory outcomes with hearing aids, the panel suggests using simultaneous bilateral implantation over unilateral implantation while considering the patient’s age and social and working conditions.

Certainty of evidence: very low.

Strength of recommendation: conditional in favour of simultaneous bilateral implantation.

Considerations in subgroups: simultaneous bilateral CI is especially indicated in the following patients:

  • associated disabilities (e.g., deaf-blind, progressive neurodegenerative disease);
  • risk of cochlear ossification (meningitis, cochlear otosclerosis, previous otological surgery, Cogan syndrome), although in this subgroup the benefits achieved are often lower than the average in adult patients with normal anatomy;
  • young patients (working or studying).

Considerations for implementation: the considerations suggested for PICO 1 are also valid for PICO 2.

Key Question 3. In an adult patient (age ≥ 18 years) with bilateral severe-profound hearing loss (PTA 0.5-1-2-4 kHz ≥ 75 dB), unilateral cochlear implant user, and poor performance/unsatisfactory results with hearing aids, is cochlear implantation in the second ear (sequential implantation) indicated?

A unilateral implant provides adequate perceptual abilities in silent environments, but does not allow the patient to benefit from the advantages provided by binaural hearing in competitive environments. The mechanisms of binaurality, in fact, through the integration of signals from both sides, improve perception in noisy environment 47 and optimise the ability to localise the sound source and control environment 48, resulting in improved quality of life and reduced listening fatigue49. The use of a hearing aid in the ear contralateral to the implant, encouraged for the purpose of keeping it actively stimulated, is unable to restore the mechanisms of binaurality and provide an advantage for perceptual purposes, and is often rejected by patients. Sequential implantation in the second ear may allow the possibility of restoring the benefits of binaural hearing.

One randomised trial 50 and 9 observational studies reported in 10 publications 51-60 with a total of 344 patients included were identified.

Most of the observational studies evaluated intrasubject benefit assessments, comparing outcomes related to the first implant with outcomes at a varying distance of time after activation of the second implant.

Speech perception in quiet was examined in 6 studies 51,52,54,57,58,60; all studies showed a positive trend, but only 2 studies 52,61 found statistically significant improvements in all conditions tested. This discordance can be attributed to several factors, including high performance with the first implant and low sample size.

Speech perception in noise has been investigated in 7 studies 52-55,57,58,60, 4 of which reported in 5 publications 53,55,56,58,60, finding statistically significant results in favour of bilateral implantation; however, in some studies, the benefit from second implantation varied according to the location of the signal and noise in the tests.

Localisation ability was examined in 3 studies reported in 4 articles with intrasubject analysis 53,55,56,59. Although the investigations differed in methodology, number of speakers, and stimuli used, all studies demonstrated significant improvements in localisation accuracy with bilateral implantation.

Subjective benefits, as measured by the SSQ, were evaluated in the randomised trial 50 and 2 observational studies 53,54. All studies showed improvement related to binaural stimulation, with particular relevance to spatial hearing dimension 50. The other parameters measured showed improvement, demonstrating an incremental trend, but not reaching statistical significance.

Specific adverse events compared with sequential implantation have been evaluated in only 2 studies 50,57 and were infrequent overall; the randomised trial 50 reported marked worsening of tinnitus in 8% of cases, while the observational study 57 reported the case of a patient who discontinued use of the processor one week after the second implant was activated, having been unable to integrate the separate signals from the two sides. The expected frequency of intervention-related adverse events does not differ from that observed with unilateral implantation.

COST EFFECTIVENESS

Two studies comparing sequential bilateral implantation versus no intervention extracted from a systematic review 46 identified an incremental cost-effectiveness ratio (ICER) for sequential bilateral implantation of $48,798/QALY (57% for the willingness to pay 100,000 reference value). The minimum and maximum values were $16,047/QALY and $55,020/QALY, respectively, and showed a wide variability, which depended on the values used in the definition of quality of life by the different studies, the study methodology, and the reference time horizon.

Recommendation: for adult patients (age ≥ 18 years) single-lateral cochlear implant recipients with contralateral severe-profound hearing loss (PTA 0.5-1-2-4 kHz ≥ 75 dB) and poor performance/unsatisfactory outcomes with hearing aids, the panel suggests using cochlear implantation in the contralateral ear (sequential implantation) versus no intervention or use of hearing aids.

Certainty of evidence: very low.

Strength of recommendation: conditional in favour of sequential implantation in the second ear.

Considerations in subgroups: the recommendation is particularly indicated for individuals with severe visual impairment, in whom control environmental and interpersonal communication are primarily dependent on auditory input, and in patients with autoimmune or infectious diseases (e.g., meningitis) with possible evolution toward ossification of the cochlea. Furthermore, it is particularly indicated for individuals of working age to promote greater adequacy in work environments or in students, in whom restoration of binaural hearing is able to reduce strain in listening and thus promote learning.

Considerations for implementation: it is recommended that the pre-implant audiological evaluation of patients candidate to the cochlear implantation in the second ear (sequential implantation) include evaluation by free-field tonal and vocal audiometry with implant and with possible prosthetic contralateral, individually and in combination, and tests of speech perception in quiet and with competing noise. Time elapsed from the first implant should also be considered, especially for patients who are not wearing the contralateral prosthesis, possible anaesthesiologic risks, and, in the case of malformations, any surgical risks associated with the procedure.

Pre- and postoperative patient management and follow-up require a dedicated multidisciplinary team including audiologist, otosurgeon, otolaryngologist, audiometrist, speech pathologist, radiologist, and hearing aid specialist.

Key Question 4. In an adult patient (age ≥ 18 years) with asymmetrical hearing loss (worse ear with severe-profound hearing loss i.e., PTA 0.5-1-2-4 kHz ≥ 75 dB, better ear with PTA > 30 dB and < 75 dB and interaural difference PTA ≥ 30 dB) and poor performance/unsatisfactory results with hearing aids, is cochlear implantation in the worse ear indicated?

In asymmetrical hearing loss, the PTA hearing threshold for the worse ear is ≥ 75 dB hearing loss and the PTA for the better ear is > 30 dB and < 75 dB hearing loss. The airway gap between the two ears is ≥ 30 dB hearing loss 61. Though the hearing of the side with the lesser degree of loss can be rehabilitated with a traditional hearing aid, the same aid, however, does not fully rehabilitate the side with greater loss, especially if the loss of the worse side is even greater with a PTA > 75 dB. Traditionally, an asymmetric hearing loss was treated with a single hearing aid fitted to the ear with the better hearing as it was sufficient for listening in favourable environmental situations (e.g., listening in a quiet environment). However, such listening is limiting as there is a loss of binaurality (listening from both sides). Binaural listening is, in fact, necessary for sound localisation skills 48, understanding in noise 47 and consequently for optimising non-audiological parameters such as quality of life 49.

Only one systematic review was identified 62 that included 2 studies with 10 participants each with asymmetric hearing loss 6,64. Both studies demonstrated significant improvements in speech perception in silence between pre- and post-implantation assessed after 6 and 12 months of follow-up. One study also reported improvement in speech perception in noise. The other study found improvement in localisation skills. One study showed improved subjective benefits assessed with the SSQ questionnaire, especially in scales related to listening speech, spatiality, and sound quality.

The expected frequency of intervention-related adverse events does not differ from that observed in patients who receive unilateral implantation in case of symmetrical hearing loss.

COST EFFECTIVENESS

No study evaluating cost effectiveness of cochlear implantation in adult patients (age ≥ 18 years) with asymmetrical hearing loss was identified.

Recommendation: for adult patients (age ≥ 18 years) with asymmetrical hearing loss (worse ear with severe-profound hearing loss i.e., PTA 0.5-1-2-4 kHz ≥ 75 dB, better ear with PTA > 30 dB and < 75 dB and interaural difference PTA ≥ 30 dB) and poor performance/unsatisfactory outcome with hearing aids, the panel suggests cochlear implantation in the worse ear.

Certainty of evidence: very low.

Strength of recommendation: conditional in favour of cochlear implantation in the worse ear.

Considerations in subgroups: the recommendation is particularly intended for patients with autoimmune or post-meningitis disease due to possible cochlear ossification and progressiveness of hearing impairment which may lead to bilateral hearing loss that is not restorable with traditional hearing aids. It is particularly indicated for individuals who are also visually impaired to give them the opportunity to have the best possible sensory input and consequently improve autonomy. Finally, it is particularly indicated for younger working individuals and for students.

Considerations for implementation: the implementation considerations suggested for PICO 1 are also valid for PICO 4.

Key Question 5. In an adult patient (age ≥ 18 years) with severe-profound hearing loss in the worse ear (so-called single-sided deafness) and hearing threshold in the better ear PTA ≤ 30 dB, is cochlear implantation in the worse ear indicated?

Single-sided deafness (SSD, profound-severe hearing loss in the worse ear and a hearing threshold in the better ear with PTA ≤ 30 dB) prevents binaural acoustic stimulation, resulting in reduced spatial localisation abilities of the sound source and reduced speech perception abilities in the presence of background noise. At present, cochlear implantation surgery in the affected ear is the only solution that can stimulate the ear with deafness in this type of patient and thus restore binaural stimulation. The FDA approved the use of one brand of CI in patients with SSD in 2019 and another brand in 2022 5.

Eight systematic reviews were identified that included studies with patients with unilateral deafness; 4 reviews included patients with profound unilateral deafness of any origin 65-68, 2 reviews included only patients with Meniere’s disease 23,69; one review included only patients with sporadic vestibular schwannoma 70; and one review included only patients in whom the onset of deep unilateral deafness was acute and rapidly progressive71.

Reviews have reported improvement in speech perception in general 70 and more specifically in silence 23,66,69 and noise 65,66 in most studies. In one review 68, no significant changes after implantation in speech perception ability in noise were reported.

The expected frequency of intervention-related adverse events did not differ from that in patients who received unilateral implantation in case of symmetrical hearing loss.

COST EFFECTIVENESS

Two studies have been identified: an HTA report conducted in Canada 72 and a cost effectiveness study conducted with the perspective of the Austrian and German Health Service 73, which reported, respectively, an ICER of $18,148 (willingness to pay $100,000/QALY) and an ICER of 34,845.20 euros (willingness to pay Austria for 2019 euros 40,458; Germany for 2019 euros 38,814). These studies have shown that in settings other than Italy, CI is cost effective with improvement in QALY indices compared with no intervention in adults with SDD in whom all other forms of amplification were unsuccessful.

Recommendation: for adult patients (age ≥ 18 years) with severe-profound hearing loss in the worse ear (so-called single-sided deafness) and hearing threshold in the better ear PTA ≤ 30 dB, the panel suggests cochlear implantation in the worse ear.

Certainty of evidence: very low.

Strength of recommendation: conditional in favour of cochlear implantation in the worse ear.

Considerations in subgroups: the recommendation is particularly intended for patients with disabling tinnitus, patients with a risk of cochlear ossification, such as those with autoimmune disease or post-meningitis deafness, or forms of sudden hearing loss with a tendency to cochlear obstruction/ossification, as well as for patients with progressive forms of hearing loss (e.g., wide vestibular aqueduct, cytomegalovirus-related forms) that can lead to hearing loss over time in the better ear and thus to bilateral hearing loss that cannot be restored with traditional hearing aids. Preimplant audiological evaluation should consider the time of deprivation of deaf ear and the dominance of the hearing ear, which can have a major influence on clinical outcomes and the patient’s expectations (e.g. high risk of non-user). It is particularly indicated for all individuals who are also visually impaired to give them the opportunity to have the best sensory input and consequently improve autonomies. Finally, it is particularly indented for younger working subjects or students.

Considerations for implementation: the implementation considerations suggested for PICO 1 are also valid for PICO 5.

Equity, feasibility and acceptability of cochlear implantation

The panel judged that cochlear implantation probably has no impact on equity as adequate care is impartially guaranteed throughout Italy, and that overall it is well accepted, even if cosmetic appearance may be a concern for patients and that there are no issues of feasibility.

Discussion and conclusions

The systematic research of the available scientific literature found a scarcity of randomised trials and an overall poor quality of conduct and reporting of both primary studies and systematic reviews. Notwithstanding, in this field, uncontrolled case series with evaluation of outcomes before and after implantation may provide acceptable evidence. Given the stable and chronic nature of the condition, further studies should enroll a larger number of participants and use consistent instrument and scales to evaluate hearing outcomes, in order to increase comparability of results across studies and pooling of data in meta-analysis.

Acknowledgements

The authors thank Marta Monteforte, Veronica Andrea Fittipaldo, Marien Gonzalez Lorenzo (Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri) for the methodological support.

Conflict of interest statement

Marinella Majorano: research grants (to Institution) from Cochlear srl. Diego Zanetti: registration fees for scientific conferences and reimbursement of travel or living expenses. Co-funding to Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano for scholarship for the purpose of supporting research. Medel Italia, Cochlear Italia, Amplifon, Audionova, Audiomedica, Fonema. The other authors declare no conflict of interest.

Funding

Funding for this study was provided by the AOOI (Associazione Otorinolaringoiatri Ospedalieri Italiani) Foundation.

Author contributions

SG, PM, DZ, PT, FA, CB, MN, SF, GG, EM, GC, MM, DC, UB, FF: formed the Panel Group. The Authors equally contributed to the critical appraisal of the evidence and the formulation of recommendations. SG, FF, DZ, FA: wrote the draft of the manuscript, all the authors critically revised and gave important intellectual content and final approval of the version to be published; SM, MC: chaired the method group: they performed the systematic review of literature and guided the panel to develop the statements.

Ethical consideration

Not applicable.

History

Received: May 20, 2024

Accepted: July 22, 2024

Figures and tables

PICO Recommendation Certainty of evidence Strength of recommendation
1 In an adult patient (age ≥ 18 years) with bilateral severe-deep hearing loss (THA 0.5-1-2-4 KHz ≥ 75 dB) and poor performance/unsatisfactory outcomes with hearing aids, is cochlear implantation indicated? For adult patients (age ≥ 18 years) with bilateral severe-profound hearing loss (PTA* 0.5-1-2-4 KHz ≥ 75 dB) and poor performance/unsatisfactory outcomes with hearing aids, panel recommends cochlear implantation (unilateral, bilateral simultaneous, bilateral sequential) over hearing aids/no intervention Moderate for desirable outcome quality of life, judged by the panel to be of critical importance, very low for desirable outcomes perception of language/communication, low for undesirable outcomes Strong in favour of cochlear implant
2 In an adult patient (age ≥ 18 years) with bilateral severe-deep hearing loss (THA 0.5-1-2-4 KHz ≥ 75 dB) and poor performance/unsatisfactory outcomes with hearing aids, is bilateral cochlear implantation indicated? For adult patients (age ≥ 18 years) with bilateral severe-profound hearing loss (PTA 0.5-1-2-4 KHz ≥ 75 dB) and poor performance/unsatisfactory outcomes with hearing aids, panel suggests using simultaneous bilateral implantation over unilateral implantation considering the patient’s age and social and working conditions Very low Conditional in favour of simultaneous bilateral implantation
3 In an adult patient (age ≥ 18 years) with bilateral severe-deep hearing loss (THA 0.5-1-2-4 KHz ≥ 75 dB), unilateral cochlear implant wearer, and poor performance/unsatisfactory results with hearing aids, is cochlear implantation in the second ear (sequential implantation) indicated? For adult patients (age ≥ 18 years) single-lateral cochlear implant recipients with contralateral severe-profound hearing loss (PTA 0.5-1-2-4 KHz ≥ 75 dB) and poor performance/unsatisfactory outcomes with hearing aids, panel suggests using cochlear implantation in the contralateral ear (sequential implantation) versus no intervention or use of hearing aids Very low Conditional in favour of sequential implantation in the second ear
4 In an adult patient (age ≥ 18 years) with asymmetrical hearing loss (worst ear with severe-deep hearing loss i.e., PTA 0.5-1-2-4 KHz ≥ 75 dB, best ear with PTA > 30 dB and < 75 dB and interaural difference PTA ≥ 30 dB) and poor performance/unsatisfactory results with hearing aids, is cochlear implantation in the worst ear indicated? For adult patients (age ≥ 18 years) with asymmetrical hearing loss (worst ear with severe-profound hearing loss i.e., PTA 0.5-1-2-4 KHz ≥ 75 dB, best ear with PTA > 30 dB and < 75 dB and interaural difference PTA ≥ 30 dB) and poor performance/unsatisfactory outcome with hearing aids, panel suggests cochlear implantation in the worst ear Very low Conditional in favour of cochlear implantation in the worst ear
5 In an adult patient (age ≥ 18 years) with severe-profound hearing loss in the worst ear (so-called Single Sided Deafness: SSD) and hearing threshold in the best ear PTA ≤ 30 dB, is cochlear implantation in the worst ear indicated? For adult patients (age ≥ 18 years) with severe-profound hearing loss in the worst ear (so-called Single Sided Deafness: SSD) and hearing threshold in the best ear PTA ≤ 30 dB, panel suggests cochlear implantation in the worst ear Very low Conditional in favour of cochlear implantation in the worst ear
GRADE Working Group grades of evidence: High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect.
Table I. PICO questions about cochlear implant (CI) procedure in adult recipients.

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Authors

Stefano Berrettini - Otolaryngology Audiology and Phoniatrics Unit, Pisa University Hospital, Pisa, Italy

Domenico Cuda - Department of Otolaryngology, AUSL Piacenza, Italy; Department of Medicine and Surgery, University of Parma, Italy

Silvia Minozzi - Laboratory of Systematic Review Methodology and Guideline Development. Mario Negri Institute for Pharmacological Research IRCCS, Milan, Italy

Franca Artioli - Otolaryngology Unit, Modena University Hospital, Modena, Italy

Umberto Barbieri - Patient representative

Cristian Borghi - Amplifon Italy SpA; University of Padua, Padua, Italy; University of Parma, Parma, Italy

Eliana Cristofari - Audiovestibology Cochlear Implant Center, Department of Neurosciences - ASST Settelaghi, Varese, Italy

Giorgio Conte - Neuroradiology Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy; Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy

Davide Cornolti - Association for Deafness and Cochlear Implants - ODV (A.S.I.C.-ODV), Lucca, Italy; Institute of Clinical Phisiology (IFC), CNR Pisa, Italy

Diego di Lisi - Section of Audiology and Cochlear Implant, Section of Otolaryngology 3, Martini Hospital,Torino, Italy

Anna Rita Fetoni - Department of Neurosciences, Reproductive Sciences, and Odontostomatology; Unity of Audiology and Vestibology, University Hospital Federico II, University of Naples Federico II, Naples, Italy

Simona Fiori - Neuroscience Department, Meyer Children’s Hospital, Florence, Italy; University of Florence, Florence, Italy

Elisabetta Genovese - Department of Maternal, Infant, and Adult Medical and Surgical Sciences, University of Modena and Reggio Emilia

Giorgia Girotto - Department of Medical, Surgical, and Health Sciences, University of Trieste, Trieste, Italy; IRCCS Burlo Garofolo, Trieste, Italy

Marinella Majorano - Department of Human Sciences, University of Verona, Verona, Italy

Pasquale Marsella - UOC of Audiology and Otosurgery, Cochlear Implant and Implantable Prosthesis Center, Pediatric Hospital “Bambino Gesù” - IRCCS Rome, Italy

Emanuele Marzetti - University Hospital Foundation “A. Gemelli” IRCCS, Rome, Italy; Department of Geriatrics, Orthopedics and Rheumatology, Università Cattolica del Sacro Cuore, Rome, Italy

Maria Nicastri - UOC Otolaryngology-Cochlear Implant Centre; Policlinico Umberto I, Rome, Italy

Gaetano Paludetti - Otolaryngology Unit, University Hospital Foundation A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy

Nicola Quaranta - Department of Translational Biomedicine and Neurosciences, University of Bari “Aldo Moro”, Bari, Italy

Patrizia Trevisi - Otolaryngology Unit, Department of Neurosciences, University Hospital of Padua, Padua, Italy

Diego Zanetti - Section of Audiology; Foundation IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy

Michela Cinquini - Laboratory of Systematic Review Methodology and Guideline Development. Mario Negri Institute for Pharmacological Research IRCCS, Milan, Italy

Francesca Forli - Otolaryngology Audiology and Phoniatrics Unit, Pisa University Hospital, Pisa, Italy; Hearing Implant Section Karolinska Institutet, Stockholm, Sweden

Sara Ghiselli - Department of Otolaryngology, AUSL Piacenza, Italy

How to Cite
Berrettini, S., Cuda, D., Minozzi, S., Artioli, F., Barbieri, U., Borghi, C., Cristofari, E., Conte, G., Cornolti, D., di Lisi, D., Fetoni, A. R. ., Fiori, S., Genovese, E., Girotto, G., Majorano, M., Marsella, P., Marzetti, E., Nicastri, M., Paludetti, G., Quaranta, N., Trevisi, P., Zanetti, D., Cinquini, M., Forli, F., & Ghiselli, S. (2025). Cochlear implant procedure. Italian Clinical Practice Guidelines of the Italian Society of Otorhinolaryngology (SIOeChCF) and Italian Society of Audiology and Phoniatrics (SIAF). Part 1: cochlear implants in adults. ACTA Otorhinolaryngologica Italica, 45(1), 47–57. https://doi.org/10.14639/0392-100X-N3081
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