Hearing Preservation in Cochlear Implantation Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUMC Utrecht

About this trial

In order to preserve the residual hearing in patients with sensorineural hearing loss (SNHL) receiving a cochlear implant (CI), the insertion trauma to the delicate and microscopic structures of the cochlea needs to be minimized. The surgical procedure starts with the conventional mastoidectomy-posterior tympanotomy (MPT) approach to the middle ear, and is followed by accessing the cochlea, with either a cochleostomy (CO) or via the round window (RW). Both techniques have their benefits and disadvantages. Another aspect is the design of the electrode array. There are fundamentally two different designs: a \*straight\* lateral wall lying electrode array (LW), or a \*pre-curved\* perimodiolar cochlear lying electrode array (PM). Interestingly, until now, the best surgical approach and type of implant is unknown. Our hypothesis is that the combination of a RW approach and a LW lying electrode array minimizes insertion trauma, leading to better hearing outcome for SNHL patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Severe hearing loss, CI candidate

18 years of age or older

normal function of middle ear (i.e. no acute middle ear infections)

dutch language proficiency

Disqualifiers

prior otologic surgery in the implanted ear (excluding tympanostomy tube placement)

inner ear malformation present in the ear to be implanted (i.e. ossification, Mondini malformation)

retrocochlear pathology present in the auditory system to be implanted

neurocognitive disorders

Trial design

Design model

Sequential

Treatments tested in this trial

  • Round window insertion

    Procedure/Surgery

    Insertion of the electrode array via the round window.

  • Cochleostomy insertion

    Procedure/Surgery

    Insertion of the electrode array via cochleostomy.

  • Lateral wall array

    Device

    Lateral wall electrode array from Advanced Bionics.

  • Periomodiolar electrode array

    Device

    Perimodiolar MidScala electrode array from Advanced Bionics.

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: Group 1: RW and LWOther 2 interventions
Group B: Group 2: RW and PMOther 2 interventions
Group C: Group 3: CO and LWOther 2 interventions
Group D: Group 4: CO + PMOther 2 interventions

Trial outcomes

Primary outcomes

1

Hearing preservation

Hearing preservation is the main outcome, which will be expressed in percentage. Hearing preservation is calculated by using the preoperative and postoperative puretoneaudiometry (PTA).

Time frame
12 months

Secondary outcomes

1

Scalar position of the electrode array

Scalar position of the electrode array (scala tympani or scala vestibuli assessed by CB-CT)

Time frame
12 months
2

Electrocochleography

ECochG (among others amplitude in µV) and eCAP (among others amplitude in µV) potentials

Time frame
12 months
3

Speech perception

Speech perception test with/without noise in CVC words correct score (in percentage) with signal to noise ratio of 10 dB.

Time frame
12 months

Other outcomes

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