Società Italiana di Medicina Subacquea ed Iperbarica Article

The new regulatory framework following Law No. 24 of March 8, 2017 (the Gelli Law) led to establishing the National Guidelines System (SNLG) through the Ministerial Decree of February 27, 2018. Managed by the Istituto Superiore di Sanità (ISS) via the National Center for Clinical Governance and Care Excellence, this system aims to standardize and improve healthcare practices by providing evidence-based guidelines. This initiative enhances the quality and safety of care and serves as a reference for medical liability assessments.

Developing the methodological and operational manuals for producing guidelines and good clinical practices ensures the scientific rigor and applicability of clinical guidelines in the Italian healthcare system. The emphasis on transparency, collaboration with scientific societies, and continuous updating of guidelines reflects a broader effort to align medical practices with international standards. Furthermore, the link between guidelines and legal responsibility underscores the dual purpose of the SNLG: improving healthcare quality while also serving as a reference in medico-legal contexts.

The Italian Society of Underwater and Hyperbaric Medicine (SIMSI) is included in the List of Scientific Societies and Technical-Scientific Associations of Healthcare Professions pursuant to the Ministerial Decree of August 2, 2017. https://www.salute.gov.it/imgs/C_17_pagineAree_4834_16_file.pdf

In July 2023, SIMSI in collaboration with Italian Navy's Health Inspectorate, "Ispettorato di Sanità della Marina Militare Italiana," (SIOeChF): The Italian Society of Otorhinolaryngology and Cervico-Facial Surgery, (SIAARTI): The Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care,  (SIAF): The Italian Society of Audiology and Phoniatrics,  (SIMEU): The Italian Society of Emergency-Urgency Medicine,  (ASPaTI): The Association of Patients Treated with Hyperbaric Oxygen Therapy,  (ANCIP): The National Association of Private Hyperbaric Centres, Otosub, submitted a guideline proposal, "Therapies for Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)" to the National Center for Clinical Governance and Care Excellence, which was evaluated and approved on July 12, 2024. https://www.iss.it/en/-/terapie-ipoacusia-improvvisa-neurosensoriale

Key Points

Recommended Treatments

1. Combination Therapy (Strong Recommendation, High-Quality Evidence)
   • The combined use of systemic and/or intratympanic corticosteroids (CSI) with Hyperbaric Oxygen Therapy (HBOT) is more effective than corticosteroids alone in the initial treatment of ISSNHL.
   • Patients receiving HBOT plus corticosteroids showed greater hearing recovery than those on corticosteroids alone.
2. Timing of Treatment (Conditional Recommendation, Low-Quality Evidence)
   • The best results are achieved if treatment begins within 15 days of onset.
   • If treatment within 15 days is not possible, initiation within one month is still considered beneficial.

Effectiveness & Safety

• HBOT + corticosteroids lead to significant hearing improvement based on clinical trials.
• Side effects of HBOT are minor (e.g., middle ear barotrauma in <4% of patients).

Economic Considerations

• Hearing loss has a major socioeconomic impact, increasing healthcare costs and reducing quality of life.
• The guidelines emphasize early intervention to reduce long-term healthcare burdens and the need for hearing aids.

Conclusion

The SIMSI guidelines support HBOT in combination with corticosteroids as the standard treatment for ISSNHL, reinforcing the importance of early intervention and multidisciplinary management to optimize patient outcomes​.

Dott. Luigi Santarella
SIMSI