Tinnitus reduction in single-sided deafness: cochlear implant, bone conduction device and CROS hearing aid (CINGLE randomized controlled trial)

Record details

Authors: Wendrich AW, Assouly KKS, van Heteren JAA, Peters JPM, Grolman W, Stokroos RJ, Versnel H, Smit AL
Journal / source: Frontiers in Neurology (2024)
Design: Single-centre RCT: 2:3:3 allocation to cochlear implant, or to trial periods of a bone conduction device then CROS (or the reverse); after the trial periods patients chose a device or no treatment, so the non-implant comparison groups are self-selected
Sample: 120 adults with single-sided deafness randomized; at the start of follow-up: 28 implanted, 25 bone conduction device, 34 CROS, 26 no treatment
Primary endpoint: Tinnitus outcomes (THI, TQ, VAS, HADS) were secondary; the trial was designed around hearing in single-sided deafness
Randomized: Yes · Sham/placebo-controlled: No · Independent of the manufacturer: No

What this research found

At 24 months the implant group improved by a median of 23 THI points, 17 TQ points and 60 VAS points from baseline (all p<0.001), already at 3 months; the bone conduction group improved on TQ and VAS; CROS and no treatment showed no significant change. Implant vs no treatment was significant on THI, TQ and VAS; implant vs the device groups was significant for VAS but not reported significant for THI or TQ.

Tinnitus was a secondary outcome in a single-centre trial; the significance threshold was Bonferroni-corrected, and missing data rose to about 20% by 24 months. This is a trial in people with single-sided deafness, not evidence for implantation in people without qualifying hearing loss.

Limitations and conflicts of interest

Secondary outcome; single centre; self-selected non-implant comparison groups; manufacturer funding; single-sided deafness only.

Funding / conflicts: Funded by Cochlear Ltd, a cochlear implant manufacturer (the funder is reported to have had no role in design, analysis or publication); one author was employed by Cochlear Technology Centre Belgium; the trial used Cochlear implants and Baha devices.

Primary sources

Used as evidence for

Cochlear implants (for qualifying hearing loss)

This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.