Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 2

Conditions: Hearing Loss

Treatments: Drug: Cochlear Implantation+dexamethasone+hyaluronic acid; Device: Cochlear Implantation; Drug: Cochlear Implantation+dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01588925

0297/11

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 3 patient groups

Control group

Experimental group

Description:

Cochlear Implantation

Treatment:

Device: Cochlear Implantation

Dexamethasone

Active Comparator group

Description:

Cochlear implantation using topical dexamethasone

Treatment:

Drug: Cochlear Implantation+dexamethasone

Device: Cochlear Implantation

Dexamethasone+Hyaluronic acid

Active Comparator group

Description:

Cochlear implantation using topical dexamethasone associated with hyaluronic acid

Treatment:

Device: Cochlear Implantation

Drug: Cochlear Implantation+dexamethasone+hyaluronic acid