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Comparing AC102 to steroids for sudden hearing loss treatment

Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic Sudden Sensorineural Hearing Loss

Phase 2 Interventional AudioCure Pharma GmbH · NCT05776459

This study is testing whether a new injection called AC102 can help adults with sudden hearing loss feel better compared to traditional steroid pills.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment210 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorAudioCure Pharma GmbH Industry-sponsored
Locations40 sites (Graz and 39 other locations)
Trial IDNCT05776459 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial aims to evaluate the safety, tolerability, and efficacy of AC102, administered as a single intratympanic injection, in comparison to oral steroid treatment for adults with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL). Participants will be randomly assigned to receive either AC102, prednisolone, or placebo. The study focuses on patients who have experienced unilateral ISSNHL within a specific time frame and meet certain audiometric criteria. The goal is to determine if AC102 can provide a more effective treatment option than traditional steroid therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with unilateral ISSNHL that began 24 to 120 hours prior to enrollment.

Not a fit: Patients with bilateral hearing loss or those with a history of ISSNHL in the affected ear within the past year may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, potentially more effective option for patients suffering from sudden hearing loss.

How similar studies have performed: While there have been studies on steroid treatments for ISSNHL, the use of AC102 as an alternative is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female patients aged between 18 and 85 years
* Unilateral ISSNHL
* Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization
* An absolute air conduction hearing threshold of at least 65 dB,
* Patients with a relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear

Exclusion Criteria:

* Insufficient handling of the language used in the speech audiometry tests
* Bilateral hearing loss
* Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time
* Congenital hearing loss
* Conductive hearing loss or combined hearing loss determined by a 4PTA \> 10 dB
* History of ISSNHL in the past 1 years in the affected ear

Where this trial is running

Graz and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hearing Loss, SensorineuralHearing LossHearing impairmentEar DiseasesOtorhinolaryngologic DiseasesHearing Loss, UnilateralIntratympanic AdministrationRestoration of Hearing Loss
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.