Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01588925

Enrollment

Registered

2012-05-01

Start date

2011-11-30

Completion date

2014-01-31

Last updated

2014-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

Cochlear implantation, Dexamethasone, Acid, Hyaluronic

Brief summary

The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation

Detailed description

Many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the development of soft surgical techniques and pharmacological protection. In this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual hearing loss.

Interventions

DEVICECochlear Implantation

Cochlear implantation using Hybrid L24 Implant

DRUGCochlear Implantation+dexamethasone

Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window

DRUGCochlear Implantation+dexamethasone+hyaluronic acid

Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Adults (greater than 18 years old) with severe/profound, bilateral sensorineural hearing loss with indication of cochlear implantation. * Hearing thresholds better than 80 dB in 125 Hz, 90 dB in 250Hz and 100 dB in 500, 1000, 2000, 3000 and 4000 Hz in at least 3 of these frequencies

Exclusion criteria

* Malformation or cochlear ossification * Developmental Disabilities

Design outcomes

Primary

Measure	Time frame	Description
Hearing thresholds	within the first 6 months after surgery	Hearing thresholds will be measured by audiometry in the frequencies 125, 250, 500, 1000, 2000 and 4000 Hz in the preoperatory, 1 month, 3 months and 6 months after the surgery.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026