Assessment of bilateral non-cochlear hearing implants by Spanish Catalonian HTA body

In June 2020, the Agency for Health Quality and Assessment of Catalonia (AQuAS) published an assessment report on the effectiveness and safety of bilateral implantation of non-cochlear hearing implants in Spain.

The objective was to assess whether bilateral implantation of the active middle ear, brainstem, and bone conduction implants are effective and safe compared to their unilateral implantation in patients (any age) with bilateral hearing loss. Cochlear implants have been excluded from the assessment, because the common portfolio of services of orthopedic services of the National Health System (SNS) already includes the bilateral insertion of these implants and specifies in which special situations it is indicated.

Scientific review of scientific evidence was performed for the period of June 2012 to June 2017. The articles included in this search were manually checked. The evidence was categorized using the Oxford Cen­tre for Evidence-based Medicine (CEBM) scale.

Results

There were selected seven documents on the insertion of bilateral hearing aids (non-cochlear). There were no randomized clinical studies. The level of evidence was very low, according to the CEBM scale (4-5) for case series and clinical case reports.

• Active middle ear hearing aids: Three case studies on the insertion of active middle ear hearing aids of the Vibrant Soundbridge® (MED-EL) model were reviewed. Patients with this type of hearing aid demon­strated the best results in bilateral hearing, correctly locating the sound 80% of the time, as compared to 67% in patients without hearing aids. In the unilateral hearing, these patients' ability to locate the sound source was considerably worse as compared to patients without hearing aids (patients had residual hearing) and bilateral hearing aids. No stud­ies on the cost of this type of bilateral hearing aids were identified;
• Brain stem hearing aids: In the adult, objective audiological results were similar under unilateral and bilateral conditions. As for the subjective assessment, results were better under bilateral conditions, reaching 9/10 points on a visual analog scale. No studies on the cost of this type of bilateral hearing aids were iden­tified;
• Bone conduction hearing aids: The better results were demonstrated in bilat­eral hearing than unilateral in detecting the tone in silence, the threshold of speech recognition in silence, recognition of words in silence, and speech rec­ognition in a noisy environment. Both children and adult patients reported an improvement in their quality of life. No studies on the cost of this type of bilateral hearing aids were identified.

Conclusions:

• Currently, there is insufficient evidence to justify including the bilateral in­sertion of any of the three types of active hearing aids (active middle ear, brainstem, and bone conduction hearing aids) in the Na­tional Health System benefit portfolio to treat bilateral hearing loss in chil­dren and adults. The decision was based on the following reasons:
  • A low number of treated patients / inserted bilateral implants;         
  • All identified studies are case series with intrasubject comparisons;
  • The continuity of the benefits of the hearing aids or potential factors that improve or worsen prognosis were not analyzed;
  • Low evidence on safety;
  • Absence of data on costs and economic evaluations.

The full details in Spanish can be found here.

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