Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study. (CISSD)

The investigators assume that cochlear implants in this indication are not only effective but also cost-effective. The investigators' experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A comparative cost-utility analysis between the two arms, of medical consequences measured in terms of quality of life will identify a preference for a strategy. Specific binaural hearing measurements with respect to each treatment option (abstention, CROS, bone conduction device, cochlear implant) will also be collected.

Study Overview

• Status: Completed
• Conditions: Retrocochlear Pathology; Auditory Processing Disorder, Central; Major Cochlear Ossification or Malformation
• Intervention / Treatment: Device: cochlear implantation; Other: 6 months initial abstention

Detailed Description

Single sided deafness and profound asymmetrical hearing loss are impairments that significantly alter quality of life. Behavioural problems and scholar delays have been reported in children. Speech recognition with background or competing noise and sound localization are both impaired. 1/1000 new borns are affected and the incidence tends to rise in the adult population. At the moment, there is no guideline regarding the treatment of single sided deafness and asymmetrical hearing loss. Some patients don't even receive any therapeutic proposition.

Three treatment options are available :

• CROS (Contralateral Routing Of the Signal) systems that convey the auditory information from the deaf ear to the good ear using wi-fi
• bone conduction devices which use transcranial conduction to convey auditory information from the poor ear to the good ear
• cochlear implants that directly stimulate afferent fibers of auditory nerve in the poor ear Cochlear implantation is therefore the only treatment which restores stimulation in the poor ear. Its efficacy in single sided deafness associated with incapacitating tinnitus have been demonstrated by Pr Van de Heyning (Leeuven, Be) and colleagues. Its interest has been compared to CROS systems and bone conduction devices in a valuable study conducted by S. Arndt (Pr Laszig, Freibourg, Ger). Cochlear implants provided better speech in noise recognition scores in dichotic hearing, i.e when speech and noise sources are spatially separated. Their first publication involved 11 patients but to date, more than 110 patients with single sided deafness have been included in their protocol. The efficacy of cochlear implantation has thus been validated in the treatment of single sided deafness and asymmetrical hearing loss.

The investigators assume that cochlear implants in this indication are not only effective but also cost-effective. The investigators' experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A comparative cost-utility analysis between the two arms, of medical consequences measured in terms of quality of life will identify a preference for a strategy. Specific binaural hearing measurements with respect to each treatment option (abstention, CROS, bone conduction device, cochlear implant) will also be collected.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Midi-Pyrénées
    • Toulouse, Midi-Pyrénées, France, 31059
      • University Hospital of Toulouse - Pierre Paul Riquet Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Social security affiliation
• Single sided deafness or profound asymmetrical hearing loss confirmed using pure tone audiometry and auditory brainstem responses, with or without tinnitus
• Written consent to the protocol

Exclusion Criteria:

• Retrocochlear pathology (vestibular schwannoma, severe central auditory processing disorder)
• Major cochlear ossification or malformation
• Subjects under juridical protections or tutelage measure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cochlear implantation; Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).	Device: cochlear implantation
Other: 6 months initial abstention; Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).	Other: 6 months initial abstention; Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incremental cost-utility ratio	6 months after cochlear implantation versus no treatment option

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global score of EuroQoL-5D		before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6
Global score of Nijmegen Cochlear implant Questionnaire (NCIQ)		before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6
Nijmegen Cochlear Implant Questionnaire (NCIQ): score in advanced auditory perception section		before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6
Speech Reception Thresholds	Signal to noise ratio that allows 50% words recognition) in diotic hearing, dichotic hearing and reverse dichotic hearing	before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6
Mean error angle for sound localization		before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Mathieu Marx, MD, University Hospital of Toulouse

Publications and helpful links

General Publications

• Marx M, Costa N, Lepage B, Taoui S, Molinier L, Deguine O, Fraysse B. Cochlear implantation as a treatment for single-sided deafness and asymmetric hearing loss: a randomized controlled evaluation of cost-utility. BMC Ear Nose Throat Disord. 2019 Feb 4;19:1. doi: 10.1186/s12901-019-0066-7. eCollection 2019.
• Dorbeau C, Galvin J, Fu QJ, Legris E, Marx M, Bakhos D. Binaural Perception in Single-Sided Deaf Cochlear Implant Users with Unrestricted or Restricted Acoustic Hearing in the Non-Implanted Ear. Audiol Neurootol. 2018;23(3):187-197. doi: 10.1159/000490879. Epub 2018 Oct 23.
• Marx M, Mosnier I, Vincent C, Bonne NX, Bakhos D, Lescanne E, Flament J, Bernardeschi D, Sterkers O, Fraysse B, Lepage B, Godey B, Schmerber S, Uziel A, Mondain M, Venail F, Deguine O. Treatment choice in single-sided deafness and asymmetric hearing loss. A prospective, multicentre cohort study on 155 patients. Clin Otolaryngol. 2021 Jul;46(4):736-743. doi: 10.1111/coa.13672. Epub 2021 Mar 26.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimated): July 30, 2014

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Tinnitus; Cost-utility; Cochlear implants; Asymmetrical hearing loss; Dichotic hearing; single sided deafness; Bone conduction device; Squelch effect.
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Communication Disorders; Language Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Congenital Abnormalities; Language Development Disorders; Tinnitus; Surgical Procedures, Operative; Prosthesis Implantation; Otorhinolaryngologic Surgical Procedures; Otologic Surgical Procedures; Cochlear Implantation
• Other Study ID Numbers: 13 7053 10; PRME2013 (Other Grant/Funding Number: Ministry of Health)